Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-29 @ 11:48 PM
Study NCT ID:
NCT06149468
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2023-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAP48 - Autism in Children and Adolescents
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2023-11-20', 'studyFirstSubmitQcDate': '2023-11-20', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Creation of an ADS register', 'timeFrame': 'Throughout the entire study, approximately during 5 years', 'description': 'creation of a common ASD register to collect general sociodemographic, geographic and epidemiological data, characterize the different patient profiles and accurately track development trajectories'}], 'secondaryOutcomes': [{'measure': 'Feasability assessment', 'timeFrame': 'Throughout the entire study, approximately during 5 years', 'description': 'Evaluate the feasibility and practical realization of the proposed care following a diagnosis of ASD in a child and implement protocols to improve the quality of therapy.'}, {'measure': 'Protocols development', 'timeFrame': 'Throughout the entire study, approximately during 5 years', 'description': 'Enable the development of fundamental research protocols: genetic, neurocognitive and linguistic'}, {'measure': 'Schooling evaluation', 'timeFrame': 'Throughout the entire study, approximately during 5 years', 'description': 'Evaluate the schooling of children with ASD of all ages'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'Evaluation and follow-up of children diagnosed with an autism spectrum disorder in French-speaking Belgium in order to optimize diagnostic protocols, the quality of care required and its accessibility, and to determine the impact of an autism spectrum disorder on schooling, family and society.', 'detailedDescription': 'The aims of the research project:\n\n* To collect a wide range of data in order to improve knowledge of children with autism spectrum disorder (ASD) in French-speaking Belgium by prospectively including all children and adolescents making a request to the centres of reference. The creation of a common database will make it possible to collect general socio-demographic, geographical and epidemiological data, to characterise the different profiles and to accurately monitor developmental trajectories.\n* Evaluate the feasibility and practical implementation of the treatment proposed following a diagnosis of ASD in a child.\n* Implement protocols to improve the quality of care for beneficiaries.\n* To enable the development of fundamental research protocols. Many questions remain unanswered about the genetic, neuro-cognitive and linguistic characteristics of autism. Only rigorous studies carried out on large, carefully defined samples can advance research.\n* Increase public knowledge and understanding of the ASD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'children/adolescents (under 18 years of age) who apply to an autism reference center or who are followed up in an autism reference center.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* children/adolescents (under 18 years of age) who apply to an autism reference center or who are followed up in an autism reference center from French-speaking region of Belgium.\n\nExclusion Criteria:\n\n* refusal by the family to allow their child's data to be included in the database."}, 'identificationModule': {'nctId': 'NCT06149468', 'acronym': 'CAP48-ASD', 'briefTitle': 'CAP48 - Autism in Children and Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Université Catholique de Louvain'}, 'officialTitle': 'CAP48 Medical Research Project: Autism Spectrum Disorders in Children and Adolescents', 'orgStudyIdInfo': {'id': 'CAP48 - TSA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ASD group', 'description': 'child/adolescent (under 18 years of age) applying to an autism reference center or being followed up in an autism reference center', 'interventionNames': ['Other: inclusion in the register']}], 'interventions': [{'name': 'inclusion in the register', 'type': 'OTHER', 'description': 'socio-demographic data collection and proposed therapy', 'armGroupLabels': ['ASD group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'state': 'Brussels Capital', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Marie-Cécile Nassogne, Prof', 'role': 'CONTACT', 'email': 'marie-cecile.nassogne@saintluc.uclouvain.be', 'phone': '02 764 1061'}, {'name': 'Marine Houssa, PhD', 'role': 'CONTACT', 'email': 'marine.houssa@uclouvain.be', 'phone': '010474688', 'phoneExt': '74688'}], 'facility': 'UCLouvain', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Marie-Cécile Nassogne, Prof', 'role': 'CONTACT', 'email': 'marie-cecile.nassogne@saintluc.uclouvain.be', 'phone': '027641061'}, {'name': 'Marine Houssa, PhD', 'role': 'CONTACT', 'email': 'marine.houssa@uclouvain.be', 'phone': '010474688', 'phoneExt': '74688'}], 'overallOfficials': [{'name': 'Marine Houssa, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Université Catholique de Louvain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université Catholique de Louvain', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Libre de Bruxelles', 'class': 'OTHER'}, {'name': 'Université de Namur', 'class': 'UNKNOWN'}, {'name': 'University of Mons', 'class': 'OTHER'}, {'name': 'Université de Liège', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}