Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-01-01 @ 9:32 PM
Study NCT ID:
NCT05038358
Status:
RECRUITING
Last Update Posted:
2025-04-20
First Post:
2021-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], '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': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2021-08-31', 'studyFirstSubmitQcDate': '2021-08-31', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of viable organoids for 60 days of culture maintenance.', 'timeFrame': '60 days of culture maintenance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Organoid collection from fresh human primary colonic tumor tissue'], 'conditions': ['Primary Tumor', 'Colon Tumor']}, 'descriptionModule': {'briefSummary': "Colorectal cancer is the third most common cancer worldwide and its progression-free survival is still low, around 10 months. Thirthy to 50% of patients do not respond to chemotherapy upon initiation of treatment, suggesting that early development of chemoresistance mechanisms remains a major challenge. In order to better characterize these mechanisms, the aim is to develop a model of tumoroids derived from patients with a colorectal tumors prior to any systemic anti cancer treatment. This project will both allow us to study the role of the immunological microenvironment in chemoresistance and identify new predictive markers of tumor response. It will then serve to develop innovative personalized medicine strategies by targeting the newly identified mechanisms. This study should in fine help to improve the cancer patient's care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'colorectal adenocarcinoma, naive from neo-adjuvant chemotherapy, indication of surgical resection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female over 18 years old.\n* Managed at the CHUGA for a colorectal adenocarcinoma\n* With an indication for immediate surgical resection as part of the care.\n* Patient naive from neo-adjuvant chemotherapy\n* Patient did not object to the CRC-ORGA-2 study\n\nExclusion Criteria:\n\n* Patients protected by law (pregnant or breastfeeding women, minors, patients under guardianship or trusteeship, persons deprived of their liberty or hospitalized under duress).\n* Patients with positive HIV, HBV, HCV serology.'}, 'identificationModule': {'nctId': 'NCT05038358', 'acronym': 'CRC-ORGA2', 'briefTitle': 'Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms: a Patient-derived Tumoroids Prospective Collection From Systemic Treatment Naive Tumors', 'orgStudyIdInfo': {'id': '2021-A00793-38'}}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'GAEL ROTH, MD, PHD', 'role': 'CONTACT', 'email': 'GRoth@chu-grenoble.fr'}, {'name': 'ARNAUD MILLET, MD,PHD', 'role': 'CONTACT', 'email': 'arnaud.millet@inserm.fr'}], 'facility': 'University Hospital of Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'centralContacts': [{'name': 'GAEL ROTH, MD, PHD', 'role': 'CONTACT', 'email': 'GRoth@chu-grenoble.fr', 'phone': '04 76 76 51 68', 'phoneExt': '0033'}, {'name': 'ARNAUD MILLET, MD, PHD', 'role': 'CONTACT', 'email': 'arnaud.millet@inserm.fr'}], 'overallOfficials': [{'name': 'GAEL ROTH, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'university hospital of Grenoble alpes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}