Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-03-13 @ 5:19 AM
Study NCT ID:
NCT01987518
Status:
UNKNOWN
Last Update Posted:
2018-02-28
First Post:
2013-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French Digestive Polyposis Cohorte Family Adenomatous Polyposis With APC and MYH Gene Mutations , Cowden's Disease With PTEN Gene Mutation, Peutz Jeghers Disease With STK 11 Gene Mutation ,juvénil Polyposis With SMAD 4 Gene Mutation , Serrated and Hyperplastic Polyposis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Genetic Diagnostic'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-27', 'studyFirstSubmitDate': '2013-11-12', 'studyFirstSubmitQcDate': '2013-11-12', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'genetic diagnosis or over 50 polyps in the stomach in the duodenum or in the colon', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Quality of Life']}, 'descriptionModule': {'briefSummary': 'French cohorte about polyposis digestive diseases', 'detailedDescription': 'Family Adenomatous Polyposis APC and MYH Genes Peutz Jeghers Disease Cowden Disease Festooned polyposis Juvenile polyposis Hyperplastic polyposis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Digestive Polyposis Cohort', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* APC Gene mutation\n* MYH Homozygote mutation\n* COWDEN Disease with PTEN gene mutation\n* Peutz Jeghers Disease with STK 11 gene mutation\n* Juvenile polyposis with SMAD 4 gene mutation\n\nExclusion Criteria:\n\n* heterozygote MYH Gene Mutation'}, 'identificationModule': {'nctId': 'NCT01987518', 'briefTitle': "French Digestive Polyposis Cohorte Family Adenomatous Polyposis With APC and MYH Gene Mutations , Cowden's Disease With PTEN Gene Mutation, Peutz Jeghers Disease With STK 11 Gene Mutation ,juvénil Polyposis With SMAD 4 Gene Mutation , Serrated and Hyperplastic Polyposis", 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Edouard Herriot'}, 'officialTitle': 'French Digestive Polyposis Cohorte', 'orgStudyIdInfo': {'id': 'Peps Data Base'}, 'secondaryIdInfos': [{'id': 'SISRA', 'type': 'OTHER', 'domain': 'SISRA'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'digestive polyposis', 'description': 'Family adenomatous polyposis (APC or MYH genes) Peutz Jeghers Disease Cowden Disease Festooned Polyposis Juvenile Polyposis Hyperplastic Polyposis', 'interventionNames': ['Other: Procedure surgery behavioral and genetic diagnosis', 'Procedure: quality of life after different type of surgery']}], 'interventions': [{'name': 'Procedure surgery behavioral and genetic diagnosis', 'type': 'OTHER', 'description': 'Observational Study', 'armGroupLabels': ['digestive polyposis']}, {'name': 'quality of life after different type of surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['digestive polyposis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69000', 'city': 'Lyon', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Saurin Jean Christophe, msd', 'role': 'CONTACT', 'email': 'jean-christophe.saurin@chu-lyon.fr', 'phone': '(33)0472117572'}, {'name': 'Vinet Olivier, CRA', 'role': 'CONTACT', 'email': 'olivier.vinet@chu-lyon.fr', 'phone': '(33)0472110370'}, {'name': 'jean christophe saurin, msd', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'jean christophe saurin, msd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HEH Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Edouard Herriot', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jean Christophe Saurin', 'investigatorAffiliation': 'Hôpital Edouard Herriot'}}}}