Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-07 @ 8:37 AM
Study NCT ID:
NCT03622333
Status:
UNKNOWN
Last Update Posted:
2018-08-20
First Post:
2018-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinic, Pathologic and Genetic Characterization of Patients With Familial Carcinoid Tumors (Study From the GTE, Groupe d'étude Des Tumeurs Endocrines)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D002276', 'term': 'Carcinoid Tumor'}, {'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2022-11-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-17', 'studyFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2018-08-07', 'lastUpdatePostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Deletion', 'timeFrame': 'day 0', 'description': 'Quantitative Constitutional genetic alterations detected by comparative genomic hybridization (CGH array)'}, {'measure': 'duplication', 'timeFrame': 'Day 0', 'description': 'Quantitative Constitutional genetic alterations detected by comparative genomic hybridization (CGH array)'}, {'measure': 'amplification', 'timeFrame': 'Day 0', 'description': 'Quantitative Constitutional genetic alterations detected by comparative genomic hybridization (CGH array)'}, {'measure': 'mutation', 'timeFrame': 'Day 0', 'description': 'qualitative Constitutional genetic alterations detected by NGS (Next Generation Sequencing)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuroendocrine tumors', 'carcinoid tumors', 'midgut', 'small intestine', 'genetic predisposition', 'hereditary'], 'conditions': ['Small Intestinal Carcinoid Tumors']}, 'descriptionModule': {'briefSummary': 'Small intestine carcinoid tumors are rare. Small intestine Familial Carcinoid Tumors (FCT) are defined by the occurrence of at least 2 cases of this tumor type in first- or second-degree relatives. The estimated prevalence of FCT is 2.6%-3.7% in patients with small intestine carcinoid tumors. Because of its rarity, epidemiologic, clinic and pathologic features of FCT have been scarcely described. Molecular abnormalities associated with FCT have been poorly explored. Constitutional genetic factors predisposing to FCT have not been discovered to date. Only one abnormality (mutation of the IPMK gene) has been reported in one FCT family only, but not found in other series.\n\nThe main objective of this study is to identify the constitutional factors predisposing to small-intestine FCT (and other midgut localizations: ascending colon and appendix). The secondary objectives are to describe the clinic and pathologic features associated with FCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'inclusion criteria :\n\n* Small-intestine (or ascending colon or appendix) neuroendocrine tumor (proven histologically)\n* At least one first- or second-degree relative with a small-intestine (or ascending colon or appendix) neuroendocrine tumor (proven histologically)\n* Agreement to participate to the study exclusion criteria :\n* Subjects unable to provide consent'}, 'identificationModule': {'nctId': 'NCT03622333', 'briefTitle': "Clinic, Pathologic and Genetic Characterization of Patients With Familial Carcinoid Tumors (Study From the GTE, Groupe d'étude Des Tumeurs Endocrines)", 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': "Clinic, Pathologic and Genetic Characterization of Patients With Familial Carcinoid Tumors (Study From the GTE, Groupe d'étude Des Tumeurs Endocrines)", 'orgStudyIdInfo': {'id': 'PO18020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Familial Carcinoid Tumors', 'description': 'All patients with proven Familial Carcinoid Tumors', 'interventionNames': ['Genetic: Research of constitutional genetic alterations']}], 'interventions': [{'name': 'Research of constitutional genetic alterations', 'type': 'GENETIC', 'description': 'Tumor DNA extraction Blood sample and constitutional DNA extraction CGH-array, Exome sequencing Bio-informatic analysis', 'armGroupLabels': ['Familial Carcinoid Tumors']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume CADIOT', 'role': 'CONTACT', 'email': 'gcadiot@chu-reims.fr', 'phone': '03 26 78 84 41'}], 'facility': 'Damien JOLLY', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}], 'centralContacts': [{'name': 'Guillaume CADIOT', 'role': 'CONTACT', 'email': 'gcadiot@chu-reims.fr', 'phone': '03 26 78 84 41'}, {'name': 'Louis DE MESTIER', 'role': 'CONTACT', 'email': 'louis.demestier@aphp.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}