Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-02 @ 4:10 PM
Study NCT ID:
NCT02877056
Status:
UNKNOWN
Last Update Posted:
2019-05-29
First Post:
2016-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Determinants of Response to Preoperative Therapy in Patients With Locally Advanced Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue samples taken from tumor and normal colorectal tissue during standard endoscopy.\n\nUp to eight biopsy samples of the tumor as well as up to six biopsies of the grossly normal colorectum obtained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-24', 'studyFirstSubmitDate': '2016-08-17', 'studyFirstSubmitQcDate': '2016-08-19', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive Tumor Cell Biomarkers After Chemoradiation Treatment for Colorectal Cancer', 'timeFrame': '1 day', 'description': 'Tissue taken at endoscopy undergoes testing for tumor cell biomarkers to identify patients who achieve complete response (CR).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal adenocarcinoma', 'Neoadjuvant therapy', 'Endoscopy', 'Endoscopic biopsy', 'Biomarkers', 'Genes'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this laboratory research is to look for genes that can predict which patients will achieve a complete disappearance of their colorectal cancer after treatment like chemotherapy, radiation, or other therapy.\n\nThis is an investigational study. Up to 350 patients will take part in this study. All will be enrolled at MD Anderson.', 'detailedDescription': 'Patients with colorectal cancer usually receive radiation, chemotherapy, or other therapy before they have surgery. At this time, there are no tests that can help researchers find out which patients no longer have any tumor left after completing treatment. Because of this, all patients have to have surgery to completely remove the rectum and/or part of the colon. This procedure results in lifestyle changes for the patient, which may be difficult and permanent.\n\nResearchers are looking for new ways to find out which patients will have no tumor left after treatment, so that in the future, some patients may be able to avoid surgery altogether. In this study, researchers will try to use chemical "markers" in tumor cells as a way to possibly predict whether or not the tumor is likely to disappear with treatment alone.\n\nAt MD Anderson, all patients with colorectal cancer have an endoscopy performed by their surgeon as part of standard care, before they start therapy. Endoscopy involves placing a narrow tube in the colon and/or rectum in order to see and inspect the tumor.\n\nIf you choose to take part in this study, tissue samples will be taken from the tumor and the normal areas during your standard endoscopy. If you undergo surgery, tissue samples from the tumor(s) and normal areas will also be collected. At the time of endoscopy and/or surgery, once the doctor has finished all standard tests on this tissue and has received the clinical reports on these tests, any leftover tissue samples will be collected by Dr. You or a person on her research team for research tests to look for tumor cell "markers." Researchers want to find out how these markers may have changed since you began receiving treatment for the disease.\n\nSome of the tissue from your biopsies may also be sent to the labs at University of Texas-Southwest or Natera for testing. No identifying information about you will be included with these samples. They will have a special number assigned, so that the samples being sent to UT Southwest or Natera will not be able to be connected to you in any way.\n\nThe results of these tests will not be used to make any decisions regarding treatment of your rectal cancer. There are no other tests or procedures required in this study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with Colorectal Cancer in the Gastrointestinal (GI) department at University of Texas MD Anderson Cancer Center.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with colorectal adenocarcinoma (diagnosis based on either MDACC or outside records)\n2. Patients scheduled to undergo neoadjuvant therapy per MDACC care team.\n3. Patients over 18 years of age.\n4. Patients with distant organ findings deemed to be indeterminate or metastatic will be enrolled at the surgeon's discretion.\n5. Patients who have been deemed medically safe to undergo endoscopic biopsy by the physician performing the procedure.\n6. Patients who would have typically undergone preoperative therapy followed by surgery but for specific reasons at the discretion of the treating physician underwent surgery without preoperative therapy may be enrolled at the surgeons' discretion.\n\nExclusion Criteria:\n\nN/A"}, 'identificationModule': {'nctId': 'NCT02877056', 'briefTitle': 'Molecular Determinants of Response to Preoperative Therapy in Patients With Locally Advanced Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Molecular Determinants of Response to Preoperative Therapy in Patients With Locally Advanced Colorectal Cancer', 'orgStudyIdInfo': {'id': 'LAB04-0962'}, 'secondaryIdInfos': [{'id': 'R33 CA118505-01', 'type': 'OTHER_GRANT', 'domain': 'American Society of Colon and Rectal Surgeons Research'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Colorectal Cancer', 'description': 'Participants undergo standard endoscopy before therapy. Tissue samples taken from the tumor and normal colorectal tissue.', 'interventionNames': ['Procedure: Endoscopy']}], 'interventions': [{'name': 'Endoscopy', 'type': 'PROCEDURE', 'description': 'Tissue samples taken from tumor and normal colorectal tissue during standard endoscopy before therapy.', 'armGroupLabels': ['Colorectal Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Yi-Qian N. You, MD', 'role': 'CONTACT', 'email': 'YNYou@mdanderson.org', 'phone': '713-792-6940'}], 'overallOfficials': [{'name': 'Yi-Qian N. You, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Research Foundation of the American Society of Colon and Rectal Surgeons', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}