Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-02-24 @ 8:50 AM
Study NCT ID:
NCT02305368
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2014-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Interest Chemo-oncogramme in Patients With Colonic Adenocarcinoma Stage 4
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'tumor fragment'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-26', 'studyFirstSubmitDate': '2014-11-19', 'studyFirstSubmitQcDate': '2014-11-26', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In vitro analysis of chemotherapy responses', 'timeFrame': '7 days', 'description': "Evaluate the predictive value of chemo-oncogramme on the patient's response to the same (s) chemotherapy (s)"}], 'secondaryOutcomes': [{'measure': 'quality of life', 'timeFrame': '7 days', 'description': 'Evaluate the predictive value of chemo-oncogramme on chemical toxicity and quality of life of patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '26791256', 'type': 'DERIVED', 'citation': 'Bounaix Morand du Puch C, Nouaille M, Giraud S, Labrunie A, Luce S, Preux PM, Labrousse F, Gainant A, Tubiana-Mathieu N, Le Brun-Ly V, Valleix D, Guillaudeau A, Mesturoux L, Coulibaly B, Lautrette C, Mathonnet M. Chemotherapy outcome predictive effectiveness by the Oncogramme: pilot trial on stage-IV colorectal cancer. J Transl Med. 2016 Jan 12;14:10. doi: 10.1186/s12967-016-0765-4.'}]}, 'descriptionModule': {'briefSummary': 'In patients with colonic adenocarcinoma stage 4 which are potentially resectable metastases (lung and liver metastases), treatment with chemotherapy is necessary but not end in success in 10% of cases. The development of techniques for administering personalized treatment becomes necessary for these patients. Thus, in vitro tests on cells from tumors of these patients and evaluating the effect of chemotherapy on these could be made for each patient. In France, the company develops Oncomedics these tests.\n\nThis is a pilot study that will make a first evaluation under actual conditions of chimio-oncogramme.', 'detailedDescription': "A fragment of colon tumors will be taken from a specimen or a cold biopsy, tissue from patients diagnosed with colon carcinoma metastatic (stage 4). In parallel and systematically: analysis by the pathologist of a histological section.\n\n* Culturing the cells obtained from the tumor by Oncomedics fragment in a defined medium and provided for enriching tumor cells compared to stromal cells.\n* Maintaining the cells in culture for 7 days.\n* Effects of conventional chemotherapy (corresponding to protocols) on these cells for 72 hours (growth chambers) by Oncomedics (chimio-oncogramme).\n* For each chemotherapy tested, measuring the proportion of dead cells / total cells.\n* Retained by Oncomedics results, not given to the nursing team. The patient will be treated and followed up in the usual way.\n* At the end of the study, comparing the in vitro results (chimio-oncogramme) to the patient's response to (x) the same (s) chemotherapy (s)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patient with adenocarcinoma of the colon diagnosed at stage 4 receiving standard therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with adenocarcinoma of the colon diagnosed at stage 4 receiving standard therapy\n* targets must be measurable tumor lesions (RECIST)\n* patient has not expressed opposition to the use of their residual tumor\n\nExclusion Criteria:\n\n* Against-formal indication to an indispensable para-clinical examination of the patient monitoring\n* Use of chemotherapy, hormone therapy or concomitant radiotherapy\n* Cons-indication for chemotherapy\n* Are pregnant, nursing or lack of contraception for women of childbearing age.'}, 'identificationModule': {'nctId': 'NCT02305368', 'acronym': 'Oncogramme', 'briefTitle': 'Evaluation of Interest Chemo-oncogramme in Patients With Colonic Adenocarcinoma Stage 4', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Evaluation of Interest Chemo-oncogramme in Patients With Colonic Adenocarcinoma Stage 4: a Pilot Study', 'orgStudyIdInfo': {'id': 'I09019 Oncogramme colon'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oncogramme', 'description': 'Taking a fragment of colon tumors taken from a specimen. Cells fragment are cultured for 7 days. The effects of chemotherapy are studied on these cells through chimio-oncogramme.', 'interventionNames': ['Other: Chimio-oncogramme']}], 'interventions': [{'name': 'Chimio-oncogramme', 'type': 'OTHER', 'description': 'Cells fragment are cultured for 7 days. The effects of chemotherapy are studied on these cells through chimio-oncogramme.', 'armGroupLabels': ['Oncogramme']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Muriel MATHONNET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chirurgie digestive - CHU LIMOGES'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}