Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-24 @ 3:12 AM
Study NCT ID:
NCT02965703
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2016-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 's-khan2@northwestern.edu', 'phone': '312-503-4236', 'title': 'Dr. Seema A. Khan', 'organization': 'Northwestern University'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.', 'description': 'All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Aspirin)', 'description': 'Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nAspirin: Given PO\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 7, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm II (Aspirin, Placebo)', 'description': 'Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nAspirin: Given PO\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nPlacebo Administration: Given PO\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 9, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Arm III (Placebo)', 'description': 'Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nPlacebo Administration: Given PO\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastrointestinal disorders - Other, specify', 'notes': 'Blood in stool; Blood during bowel movement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bronchial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and infestations - Other, specify', 'notes': 'Abscess left axilla', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Injury, poisoning and procedural complications - Other, specify', 'notes': 'Sprained wrist; Small cut on head; Rectal sensitivity after biopsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Papulopustular rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Renal calculi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Kidney Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ratio of Cell Proliferation to Apoptosis Biomarkers (Ki67 Index and BAX Index)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Aspirin)', 'description': 'Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nAspirin: Given PO\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}, {'id': 'OG001', 'title': 'Arm II (Aspirin, Placebo)', 'description': 'Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nAspirin: Given PO\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nPlacebo Administration: Given PO\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}, {'id': 'OG002', 'title': 'Arm III (Placebo)', 'description': 'Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nPlacebo Administration: Given PO\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'groupId': 'OG000', 'lowerLimit': '-0.26', 'upperLimit': '1.26'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.42', 'upperLimit': '0.92'}, {'value': '-0.23', 'groupId': 'OG002', 'lowerLimit': '-0.32', 'upperLimit': '-0.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to end of intervention up to 12 weeks', 'description': 'Change in the ratio of proliferation to apoptosis biomarkers (Ki67 density index: BAX density index, measured continuously after IHC staining) in colorectal mucosa of compliant participants', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with pre and post intervention samples available.'}, {'type': 'SECONDARY', 'title': 'Ratio of Cell Proliferation (Ki-67)/Apoptosis (TdT-mediated dUTP Nick End Labeling [TUNEL]) in Rectal Biopsies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Aspirin)', 'description': 'Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nAspirin: Given PO\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}, {'id': 'OG001', 'title': 'Arm II (Aspirin, Placebo)', 'description': 'Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nAspirin: Given PO\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nPlacebo Administration: Given PO\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}, {'id': 'OG002', 'title': 'Arm III (Placebo)', 'description': 'Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nPlacebo Administration: Given PO\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.27', 'groupId': 'OG000', 'lowerLimit': '-1.66', 'upperLimit': '0.99'}, {'value': '0.63', 'groupId': 'OG001', 'lowerLimit': '-0.20', 'upperLimit': '1.78'}, {'value': '-0.70', 'groupId': 'OG002', 'lowerLimit': '-2.32', 'upperLimit': '0.71'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to end of intervention up to 12 weeks', 'description': 'Change in the ratio of proliferation to apoptosis biomarkers (Ki67 density index: TUNEL density index, measured continuously after IHC staining) in colorectal mucosa of compliant participants.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with pre and post intervention samples available.'}, {'type': 'SECONDARY', 'title': 'Ratio of Cell Proliferation (Ki-67)/Necroptosis (MLKL) in Rectal Biopsies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Aspirin)', 'description': 'Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nAspirin: Given PO\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}, {'id': 'OG001', 'title': 'Arm II (Aspirin, Placebo)', 'description': 'Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nAspirin: Given PO\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nPlacebo Administration: Given PO\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}, {'id': 'OG002', 'title': 'Arm III (Placebo)', 'description': 'Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nPlacebo Administration: Given PO\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.58', 'groupId': 'OG000', 'lowerLimit': '-0.84', 'upperLimit': '0.79'}, {'value': '-0.02', 'groupId': 'OG001', 'lowerLimit': '-0.53', 'upperLimit': '0.39'}, {'value': '-0.32', 'groupId': 'OG002', 'lowerLimit': '-1.39', 'upperLimit': '0.77'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to end of intervention up to 12 weeks', 'description': 'Change in the ratio of proliferation to necroptosis biomarkers (Ki67 density index: pMLKLdensity index, measured continuously after IHC staining) in colorectal mucosa of compliant participants', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with pre and post intervention samples available.'}, {'type': 'SECONDARY', 'title': 'Fecal Occult Blood Test (Measures of Adverse Events) as Measured by Stool Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Aspirin)', 'description': 'Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nAspirin: Given PO\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}, {'id': 'OG001', 'title': 'Arm II (Aspirin, Placebo)', 'description': 'Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nAspirin: Given PO\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nPlacebo Administration: Given PO\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}, {'id': 'OG002', 'title': 'Arm III (Placebo)', 'description': 'Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nPlacebo Administration: Given PO\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to end of intervention up to 12 weeks.', 'description': 'The number of participants who started intervention and had a positive fecal occult blood test result', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with pre and post intervention samples available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Aspirin)', 'description': 'Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nAspirin: Given PO\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}, {'id': 'FG001', 'title': 'Arm II (Aspirin, Placebo)', 'description': 'Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nAspirin: Given PO\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nPlacebo Administration: Given PO\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}, {'id': 'FG002', 'title': 'Arm III (Placebo)', 'description': 'Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nPlacebo Administration: Given PO\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '81 participants were randomized. 70 out of the 81 started study agent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Aspirin)', 'description': 'Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nAspirin: Given PO\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}, {'id': 'BG001', 'title': 'Arm II (Aspirin, Placebo)', 'description': 'Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nAspirin: Given PO\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nPlacebo Administration: Given PO\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}, {'id': 'BG002', 'title': 'Arm III (Placebo)', 'description': 'Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nBiospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples\n\nPlacebo Administration: Given PO\n\nQuestionnaire Administration: Ancillary studies\n\nRectal Biopsy: Undergo rectal biopsy'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'spread': '8', 'groupId': 'BG000'}, {'value': '60', 'spread': '6', 'groupId': 'BG001'}, {'value': '57', 'spread': '6', 'groupId': 'BG002'}, {'value': '60', 'spread': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '81 participants were randomized. 70 out of the 81 started study agent.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-11', 'size': 12149310, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-11T12:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2016-11-16', 'resultsFirstSubmitDate': '2025-01-15', 'studyFirstSubmitQcDate': '2016-11-16', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-07', 'studyFirstPostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of Cell Proliferation to Apoptosis Biomarkers (Ki67 Index and BAX Index)', 'timeFrame': 'Baseline to end of intervention up to 12 weeks', 'description': 'Change in the ratio of proliferation to apoptosis biomarkers (Ki67 density index: BAX density index, measured continuously after IHC staining) in colorectal mucosa of compliant participants'}], 'secondaryOutcomes': [{'measure': 'Ratio of Cell Proliferation (Ki-67)/Apoptosis (TdT-mediated dUTP Nick End Labeling [TUNEL]) in Rectal Biopsies', 'timeFrame': 'Baseline to end of intervention up to 12 weeks', 'description': 'Change in the ratio of proliferation to apoptosis biomarkers (Ki67 density index: TUNEL density index, measured continuously after IHC staining) in colorectal mucosa of compliant participants.'}, {'measure': 'Ratio of Cell Proliferation (Ki-67)/Necroptosis (MLKL) in Rectal Biopsies', 'timeFrame': 'Baseline to end of intervention up to 12 weeks', 'description': 'Change in the ratio of proliferation to necroptosis biomarkers (Ki67 density index: pMLKLdensity index, measured continuously after IHC staining) in colorectal mucosa of compliant participants'}, {'measure': 'Fecal Occult Blood Test (Measures of Adverse Events) as Measured by Stool Samples', 'timeFrame': 'Baseline to end of intervention up to 12 weeks.', 'description': 'The number of participants who started intervention and had a positive fecal occult blood test result'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Adenoma', 'Colorectal Carcinoma']}, 'descriptionModule': {'briefSummary': 'This phase IIa trial studies how well aspirin works in preventing colorectal cancer in patients with colorectal adenoma. Aspirin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To test for the equivalency of the two aspirin schedules.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the effects of aspirin treatments on:\n\nIa. The ratio of cell proliferation (Ki-67)/apoptosis (TUNEL) in rectal biopsies; Ib. The ratio of cell proliferation (Ki-67)/necroptosis (pMLKL) in rectal biopsies; Ic. Fecal occult blood test (measures of adverse events) as measured by stool samples.\n\nEXPLORATORY OBJECTIVES:\n\nI. To evaluate the effects of aspirin treatments on:\n\nIa. Cyclooxygenase-2 (COX-2) in rectal biopsies; Ib. Bcl-2-like protein 4 (BAX) in rectal biopsies; Ic. Transient receptor potential cation channel subfamily M member (7TRPM7) in rectal biopsies; Id. Joint index of COX-2 with TRPM7 expression in rectal biopsies; Ie. Joint index of TRPM7 with BAX in rectal biopsies; If. Methylation assays using the MethylationEPIC BeadChip to identify methylation biomarkers in genes (i.e. CDKN2A \\[cell cycle regulation\\], MGMT \\[deoxyribonucleic acid (DNA) repair\\], DAPK1 \\[apoptosis\\], CDH1 \\[cell invasion\\], WNT16 \\[Wnt pathway\\] and RASSF1 \\[RAS signaling\\]) involved in colorectal carcinogenesis, and other epigenome-wide methylation biomarkers as measured in rectal biopsies; Ig. Metagenomics analysis to measure abundance of Escherichia coli (E. coli) and Fusobacterium and other microbiota in rectal swabs.\n\nOUTLINE: Patients are randomized to 1 of 3 arms.\n\nARM I: Patients receive aspirin orally (PO) daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nARM II: Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nARM III: Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.\n\nAfter completion of study, patients are followed up at 1 month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of colorectal adenoma of any grade\n* Age \\>= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of aspirin in participants \\< 18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\< 1 (Karnofsky \\>= 70%)\n* Leukocytes \\>= 3,000/microliter\n* Absolute neutrophil count \\>= 1,500/microliter\n* Platelets \\>= 150,000/microliter\n* Total bilirubin =\\< 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\< 1.5 x institutional ULN\n* Creatinine =\\< 1.5 x institutional ULN\n* Blood hemoglobin \\>= 12.0 g/dL\n* Alkaline phosphatase =\\< 1.5 x institutional ULN\n* Blood urea nitrogen (BUN) =\\< 40 mg/dL\n* Estimated glomerular filtration rate (eGFR) \\>= 45 mL/min\n* Negative fecal occult blood test\n* The effects of aspirin on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Current (within three weeks of randomization) or planned use during the study intervention of the following:\n\n * Aspirin, other nonsteroidal anti-inflammatory drugs (NSAIDs), or COX-2 inhibitors\n * Anticoagulants, anti-platelet agents, or corticosteroids\n * Gingko\n * Ethanol consumption \\> 1 standard drinks/day for women, or \\> 2 standard drinks/day for men\n * Methotrexate (MTX)\n * Study participants will be instructed to use Tylenol or some other non-excluded agent to treat common ailments (i.e. headache/minor aches and pains)\n* History of\n\n * Any invasive malignancy within the past 2 years, with the exception of non-melanoma skin cancer\n * Chronic renal diseases or liver cirrhosis\n * Diseases such as anemia, peptic ulcer, gastrointestinal bleeding, active colitis and inflammatory bowel disease\n * Hemorrhagic stroke or uncontrolled hypertension\n* Participants may not be receiving any other investigational agents\n* History of allergic reactions or intolerance attributed to aspirin or compounds of similar chemical or biologic composition\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements\n* Women who are pregnant or breastfeeding; pregnant women are excluded from this study because aspirin has the potential for abortifacient effects; because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with aspirin, breastfeeding should be discontinued if the mother is treated with aspirin'}, 'identificationModule': {'nctId': 'NCT02965703', 'briefTitle': 'Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Evaluating Intermittent Dosing of Aspirin for Colorectal Cancer Chemoprevention', 'orgStudyIdInfo': {'id': 'NCI-2016-01642'}, 'secondaryIdInfos': [{'id': 'NCI-2016-01642', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'N01-CN-2012-00035'}, {'id': 'NCI2015-06-01', 'type': 'OTHER', 'domain': 'Northwestern University'}, {'id': 'NWU2015-06-01', 'type': 'OTHER', 'domain': 'DCP'}, {'id': 'N01CN00035', 'link': 'https://reporter.nih.gov/quickSearch/N01CN00035', 'type': 'NIH'}, {'id': 'P30CA060553', 'link': 'https://reporter.nih.gov/quickSearch/P30CA060553', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (aspirin)', 'description': 'Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.', 'interventionNames': ['Drug: Aspirin', 'Procedure: Biospecimen Collection', 'Other: Questionnaire Administration', 'Procedure: Rectal Biopsy']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (aspirin, placebo)', 'description': 'Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.', 'interventionNames': ['Drug: Aspirin', 'Procedure: Biospecimen Collection', 'Other: Placebo Administration', 'Other: Questionnaire Administration', 'Procedure: Rectal Biopsy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm III (placebo)', 'description': 'Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Other: Placebo Administration', 'Other: Questionnaire Administration', 'Procedure: Rectal Biopsy']}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['Acetylsalicylic Acid', 'ASA', 'Aspergum', 'Ecotrin', 'Empirin', 'Entericin', 'Extren', 'Measurin'], 'description': 'Given PO', 'armGroupLabels': ['Arm I (aspirin)', 'Arm II (aspirin, placebo)']}, {'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo collection of blood, urine, stool, and rectal swab samples', 'armGroupLabels': ['Arm I (aspirin)', 'Arm II (aspirin, placebo)', 'Arm III (placebo)']}, {'name': 'Placebo Administration', 'type': 'OTHER', 'description': 'Given PO', 'armGroupLabels': ['Arm II (aspirin, placebo)', 'Arm III (placebo)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (aspirin)', 'Arm II (aspirin, placebo)', 'Arm III (placebo)']}, {'name': 'Rectal Biopsy', 'type': 'PROCEDURE', 'otherNames': ['Biopsy of Rectum'], 'description': 'Undergo rectal biopsy', 'armGroupLabels': ['Arm I (aspirin)', 'Arm II (aspirin, placebo)', 'Arm III (placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University/Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Qi Dai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}