Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-27 @ 4:39 PM
Study NCT ID:
NCT02903732
Status:
UNKNOWN
Last Update Posted:
2016-09-16
First Post:
2016-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autism Registry for French Guiana
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-13', 'studyFirstSubmitDate': '2016-09-06', 'studyFirstSubmitQcDate': '2016-09-13', 'lastUpdatePostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'autism spectrum disorder', 'timeFrame': '1 year (the year at age 8)', 'description': 'the number of 8 year old children with a diagnosis of autism spectrum disorder in a given year relative to the total population of children aged 8 years old in that given year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'The objective of the autism registry is to estimate the prevalence of autism in French Guiana in the cohort of children aged 8 years. Secondary objectives are to determine the prevalence of comorbidities, and to determine the theoretical and actual orientation of these children regarding care and education in a territory with significant structural deficits relative to mainland France. The outcomes of this registry will be to guide decision makers in their funding priorities to improve, screening, diagnosis, care and education for children on the autistic spectrum'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children aged 8 years will be the denominator. the numerator is children who are seeking assistance for care or educational purposes at the unique administration dealing with handicap in French Guiana', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children aged 8 years with a diagnosis of autism spectrum disorder\n\nExclusion Criteria:\n\n* refusal to participate'}, 'identificationModule': {'nctId': 'NCT02903732', 'acronym': 'REGUYAUT', 'briefTitle': 'Autism Registry for French Guiana', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Cayenne'}, 'officialTitle': 'Autism Registry for French Guiana', 'orgStudyIdInfo': {'id': 'REGUYAUT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'observational', 'type': 'OTHER', 'description': 'registry'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97306', 'city': 'Cayenne', 'state': 'French Guiana', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathieu Nacher, MD, PhD', 'role': 'CONTACT', 'email': 'mathieu.nacher@ch-cayenne.fr', 'phone': '0594395024', 'phoneExt': '5024'}], 'facility': 'Centre Hospitalier de Cayenne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Cayenne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}