Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-25 @ 2:49 PM
Study NCT ID:
NCT03951792
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2019-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue Biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2019-05-14', 'studyFirstSubmitQcDate': '2019-05-14', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DNA/RNA Biomarkers', 'timeFrame': '5 years', 'description': 'Biomarkers will be defined by extracting DNA/RNA from tissue biopsies and stored for specific gene extractions.'}, {'measure': 'Microbial 16S rDNA Biomarkers', 'timeFrame': '5 years', 'description': 'The samples will be used to partially (V3-V5 region) amplify the microbial 16S rDNA genes through a polymerase chain reaction (PCR). The PCR product will subsequently be purified and quantified before being sequenced. They will also be used for whole genome sequencing (WGS) and Methylation sequencing (Methyl-Seq). The RNA will be used for RNAseq.'}], 'secondaryOutcomes': [{'measure': 'Protein Measurements', 'timeFrame': '5 years', 'description': 'Based on our initial findings protein measurements may also be performed on any extra residual specimens.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer Colon', 'Gastrointestinal Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are trying to determine whether certain microbiome cause cancer or whether they are part of the microbiome in the gut due to the presence of cancer.', 'detailedDescription': 'The purpose of this research is to learn about how the gastrointestinal bacteria (microbiome) can contribute to colon cancer, and how it may change due to colon cancer. In addition, we are going to study the features of the microbiome that can help predict recovery after colon resection. To do this, we are going to compare the microbiome from subjects with colon cancer to subjects without colon cancer.\n\nStudy participation involves collection of stool samples before and after your surgery, as well as samples of residual (left-over) colon tissue from your surgery. We would also like to collect optional samples from your follow-up colonoscopy. You may be in the study for up to 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects undergoing bowel resection by any standard surgical approach at Mayo Clinic in Rochester, MN.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Patients undergoing bowel resection by any standard surgical approach.\n\nExclusion Criteria:\n\n* Female that are pregnant\n* Currently receiving or have received pelvic cancer radiation therapy in the past 2 weeks.\n* Currently receiving or have received chemotherapy in the past 2 weeks.'}, 'identificationModule': {'nctId': 'NCT03951792', 'briefTitle': 'Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects', 'orgStudyIdInfo': {'id': '21-001536'}, 'secondaryIdInfos': [{'id': 'R01CA179243', 'link': 'https://reporter.nih.gov/quickSearch/R01CA179243', 'type': 'NIH'}, {'id': '18-009965', 'type': 'OTHER', 'domain': 'Mayo Clinic in Rohester'}, {'id': 'P30CA015083', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015083', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Colorectal Cancer Subjects', 'description': 'Subjects under going colorectal resection with colorectal cancer will have tissue and stool collected'}, {'label': 'Benign Colon Resection Subjects', 'description': 'Subjects under going colorectal resection without colorectal cancer will have tissue and stool collected'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Nicholas L. Chia, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}