Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-02-20 @ 6:16 AM
Study NCT ID:
NCT03613194
Status:
UNKNOWN
Last Update Posted:
2018-08-03
First Post:
2018-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanistic and Molecular Study of the Process of Metastatic Dissemination in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-27', 'studyFirstSubmitDate': '2018-07-19', 'studyFirstSubmitQcDate': '2018-07-27', 'lastUpdatePostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification and characterization of the tumoral intermediaries on the overflowing peritoneal', 'timeFrame': 'Up to 24 months', 'description': 'After several separation and centrifugation steps, clusters and tumor cells are isolated and counted in the various biological samples. The different isolated intermediates will be analyzed by immunolabeling with the antibodies directed against CK20, EpCAM, Vimentine and CD45.'}, {'measure': 'Identification and characterization of the tumoral intermediaries on the portal blood', 'timeFrame': 'Up to 24 months', 'description': 'After several separation and centrifugation steps, clusters and tumor cells are isolated and counted in the various biological samples. The different isolated intermediates will be analyzed by immunolabeling with the antibodies directed against CK20, EpCAM, Vimentine and CD45.'}, {'measure': 'Identification and characterization of the tumoral intermediaries on the peripheral blood', 'timeFrame': 'Up to 24 months', 'description': 'After several separation and centrifugation steps, clusters and tumor cells are isolated and counted in the various biological samples. The different isolated intermediates will be analyzed by immunolabeling with the antibodies directed against CK20, EpCAM, Vimentine and CD45.'}, {'measure': 'Identification and characterization of the tumoral intermediaries on the hepatic metastasis and/or peritoneal)', 'timeFrame': 'Up to 24 months', 'description': 'After several separation and centrifugation steps, clusters and tumor cells are isolated and counted in the various biological samples. The different isolated intermediates will be analyzed by immunolabeling with the antibodies directed against CK20, EpCAM, Vimentine and CD45.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'To confirm the role of the collective dissemination in the mechanisms of tumoral invasion of colorectal cancers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Histological Diagnosis of stage IV colorectal cancer\n* Hepatic metastasis and/or peritoneal potentially resecable\n* Patient affiliated with a mode of the social security or recipient of such a mode\n* Information of the patient or his legal representative and collection of his assent\n\nExclusion Criteria:\n\n* None metastatic colorectal cancer\n* Cancer of appendicular origin\n* Patients deprived of liberty or unable to give his assent'}, 'identificationModule': {'nctId': 'NCT03613194', 'acronym': 'DISCOVER', 'briefTitle': 'Mechanistic and Molecular Study of the Process of Metastatic Dissemination in Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Gustave Roussy, Cancer Campus, Grand Paris'}, 'officialTitle': 'Mechanistic and Molecular Study of the Process of Metastatic Dissemination in Colorectal Cancer', 'orgStudyIdInfo': {'id': '2017-A02878-45'}, 'secondaryIdInfos': [{'id': '2017/2511', 'type': 'OTHER', 'domain': 'CSET number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with metastatic colorectal cancer', 'description': 'After inclusion in the study, eligible patients having hepatic metastases and/or péritonéales of a colorectal cancer considered as resecables will have biological and tissue samples.\n\nThe samples will be carried out at the time of the surgical gesture envisaged under general anaesthesia and will concern:\n\n* Tumoral material: primitive tumour (if available), hepatic metastases and/or peritoneal\n* Peritoneal liquid\n* none tumoral peritoneum\n* Portal blood\n* Peripheral blood\n* Cellulo-lymphatic material The necessary time to carry out the whole of these samples is estimated at 10-15 minutes maximum.\n\nIn the event of complex situations being able to complicate the surgical gesture initially envisaged or to increase by them morbidity, one or more these samples will not be carried out. This decision will be made at the discretion of the investigator.', 'interventionNames': ['Procedure: Sampling']}], 'interventions': [{'name': 'Sampling', 'type': 'PROCEDURE', 'description': 'After inclusion in the study, eligible patients having hepatic metastases and/or péritonéales of a colorectal cancer considered as resecables will have biological and tissue samples.\n\nThe samples will be carried out at the time of the surgical gesture envisaged under general anaesthesia and will concern:\n\n* Tumoral material: primitive tumour (if available), hepatic metastases and/or peritoneal\n* Peritoneal liquid\n* none tumoral peritoneum\n* Portal blood\n* Peripheral blood\n* Cellulo-lymphatic material The necessary time to carry out the whole of these samples is estimated at 10-15 minutes maximum.\n\nIn the event of complex situations being able to complicate the surgical gesture initially envisaged or to increase by them morbidity, one or more these samples will not be carried out. This decision will be made at the discretion of the investigator.', 'armGroupLabels': ['Patients with metastatic colorectal cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94805', 'city': 'Villejuif', 'state': 'Val De Marne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Diane GOERE, MD', 'role': 'CONTACT', 'email': 'diane.goere@gustaveroussy.fr', 'phone': '0142114211', 'phoneExt': '+33'}], 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Diane GOERE, MD', 'role': 'CONTACT', 'email': 'diane.goere@gustaveroussy.fr', 'phone': '0142114211', 'phoneExt': '+33'}, {'name': 'Fanny JAULIN, MD', 'role': 'CONTACT', 'email': 'fanny.jaulin@gustaveroussy.fr', 'phone': '0142114211', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}