Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT04006951
Status:
RECRUITING
Last Update Posted:
2025-02-13
First Post:
2019-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of a Clinical and Biological Database in Rectum Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2019-07-01', 'studyFirstSubmitQcDate': '2019-07-01', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who gave their consent to participate in the study', 'timeFrame': 'Until the study completion : 66 months', 'description': 'The proportion of patients who consent to participate in the study among the screened patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Colorectal cancer', 'Biological Specimen Banks'], 'conditions': ['Rectal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '21632132', 'type': 'BACKGROUND', 'citation': 'Haustermans K, Debucquoy A, Lambrecht M. The ESTRO Breur Lecture 2010: toward a tailored patient approach in rectal cancer. Radiother Oncol. 2011 Jul;100(1):15-21. doi: 10.1016/j.radonc.2011.05.024. Epub 2011 May 31.'}]}, 'descriptionModule': {'briefSummary': 'A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to Rectum Cancer.', 'detailedDescription': "In France, colorectal cancer is the second major cause of cancer-related death with 17 000 cases per year. Rectal carcinoma represents 40% of colorectal cancers.\n\nLocally advanced rectal carcinoma raises the issue of both the oncological control, local and general, and the therapeutic morbidity. Currently, pre-operative radiochemotherapy associated with radical proctectomy (TME) is the standard treatment. Radiochemotherapy improves the local control but with enhanced postoperative morbidity and poor functional results.\n\nMoreover, some patients have no downstaging (around 1/3) and the metastatic risk remains about 30%.\n\nThen, compliance to adjuvant chemotherapy is generally poor after radical proctectomy.\n\nTumor response to preoperative treatment is the major prognostic factor which reveals tumor aggressiveness. Nevertheless, at present, there are no predictive markers of tumor response.\n\nProgresses in rectal cancer management are related to sharing biological and clinical resources with scientific community.\n\nA clinical and biological collection will allow to :\n\n* develop research programs on predictive markers to pre-operative radiochemotherapy or prognostics factors to disease recurrence\n* optimize diagnostic and follow-up tests\n* develop new biomarkers to improve patient's therapeutic management\n\nIn this context, the Montpellier Cancer Institute (ICM) decided to initiate a biological collection biomedical research dedicated to the tissular and blood samples of patients with colorectal cancer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient treated at the Montpellier Cancer Institute, whatever the treatment received (systemic cancer treatment or radiotherapy or surgery)\n* Age \\> 18 years\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patient not affiliated to Social Protection system\n* Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons\n* Patient under guardianship'}, 'identificationModule': {'nctId': 'NCT04006951', 'acronym': 'BCBRectum', 'briefTitle': 'Development of a Clinical and Biological Database in Rectum Cancer', 'organization': {'class': 'OTHER', 'fullName': "Institut du Cancer de Montpellier - Val d'Aurelle"}, 'officialTitle': 'Development of a Monocentric and Prospective Clinical and Biological Database in Rectum Cancer', 'orgStudyIdInfo': {'id': 'ICM-BCB-2014/02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biological collection', 'description': 'For all the patients include in the study :\n\n* Paraffin tissue samples (if applicable) collected during pre-therapeutic rectal biopsy\n* Blood samples collected at different times : Before any treatment and Before surgery if the patient received pre-operative radiochemotherapy\n\nIn parallel to this biological collection, standardized clinical data will be entered into a database', 'interventionNames': ['Other: Biological collection']}], 'interventions': [{'name': 'Biological collection', 'type': 'OTHER', 'description': 'Blood samples are collected at different times :\n\n* Before any treatment\n* After pre-operative radiochemotherapy and before surgery (if applicable)', 'armGroupLabels': ['Biological collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34298', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe ROUANET', 'role': 'CONTACT', 'email': 'philippe.rouanet@icm.unicancer.fr', 'phone': '00467613100'}], 'facility': "ICM Val d'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Aurore MOUSSION', 'role': 'CONTACT', 'email': 'drci-icm105@icm.unicancer.fr', 'phone': '4 67 61 31 02', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'ROUANET Philippe, MD-PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut régional du Cancer Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut du Cancer de Montpellier - Val d'Aurelle", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}