Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-03-02 @ 7:43 AM
Study NCT ID:
NCT03976960
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2019-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Biological Database in Colon Cancer and Colic Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003085', 'term': 'Colic'}], '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': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2019-06-05', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of clinical risk factors for colorectal cancer', 'timeFrame': 'Until the study completion : 6 years'}, {'measure': 'Number of biological risk factors for colorectal cancer', 'timeFrame': 'Until the study completion : 6 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer', 'colon', 'tumor', 'colic'], 'conditions': ['Cancer Colon']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.google.com/search?client=firefox-b-d&sxsrf=ALeKk0251JuQRT2bZiWL8ut7KwGhX0TKeQ:1596454499279&q=Estimation+nationale+de+l%27incidence+et+de+la+mortalit%C3%A9+par+cancer+en+France+entre+1980+et+2012.+Partie+1-+Tumeurs+solides.+Traitement+:+INCA+2013.&spell=1&sa=X&ved=2ahUKEwj7lNG6-P7qAhVKxIUKHZeSCMMQBSgAegQICxAq&biw=1920&bih=1006', 'label': 'National estimate of cancer incidence and mortality in France between 1980 and 2012.'}]}, 'descriptionModule': {'briefSummary': 'Developement of a clinical and biological database in colon cancer and colic tumors in order to better understand tumor invasion and metastatic scattering processes. The investigators hope that a better understanding of tumoral invasion process will lead to the discovery of new biomarkers and new drugs.', 'detailedDescription': 'As the second leading cause of cancer-related death in France, colorectal cancer is a major public health problem. Each year, 37 000 cases are newly diagnosed in France and 17 000 patients die of the disease.\n\nColorectal cancer is due to molecular and genetic damages involved in all tumorigenesis steps, transition from healthy tissue to adenoma and finally to invasive carcinoma stage. The investigators hope that a to better understand tumor invasion and metastatic scattering processes will allow therapeutic innovation and the emergence of new biomarkers.\n\nHowever, the study of early tumorigenesis phases as well as advanced stages of the disease is currently limited due to a lack of tissue samples.\n\nIn this context, the Montpellier Cancer Institute (ICM) decided to initiate a biological collection 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\n1. Patient undergoing colon cancer surgery (stage I, II, III and IV)\n2. Patient operated for liver or lung or peritoneal carcinomatosis metastases originating from colon cancer\n3. Patient operated for pre-neoplastic lesion (adenomatous polyp /villous adenoma polyp),\n4. Patient with familial polyposis eligible for colectomy\n5. Age \\> 18 years\n6. Signed informed consent\n\nExclusion Criteria:\n\n1. Patient not affiliated to Social Protection system\n2. Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons\n3. Patient under guardianship\n4. Minor patient'}, 'identificationModule': {'nctId': 'NCT03976960', 'acronym': 'BCBCOLON', 'briefTitle': 'Clinical and Biological Database in Colon Cancer and Colic Tumors', 'organization': {'class': 'OTHER', 'fullName': "Institut du Cancer de Montpellier - Val d'Aurelle"}, 'officialTitle': 'Prospective, Multicenter, Clinical and Biological Database Set-up in Colon Cancer and Colic Tumors', 'orgStudyIdInfo': {'id': 'BCB2014/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biological collection', 'description': 'For all the patients include in the study :\n\nsamples of blood samples collected before or after surgery but also samples in paraffin-embedded tissue sections.\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': 'The biological collection will also include samples of blood samples collected before or after surgery but also samples frozen and/or paraffin-embedded tissue sections.', 'armGroupLabels': ['Biological collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34298', 'city': 'Montpellier', 'state': 'Hérault', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric Assénat, MD', 'role': 'CONTACT', 'email': 'e-assenat@chu-montpellier.fr', 'phone': '467330137', 'phoneExt': '+33'}], 'facility': 'CHRU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34298', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'ERIC ASSENAT, MD', 'role': 'CONTACT'}], 'facility': 'Institut Régional du cancer de Montpellier', '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': 'ERIC ASSENAT, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut régional du cancer de Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut du Cancer de Montpellier - Val d'Aurelle", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}