Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-01-17 @ 10:13 AM
Study NCT ID:
NCT02267161
Status:
COMPLETED
Last Update Posted:
2022-09-27
First Post:
2014-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infants With Agenesis of the Corpus Callosum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061085', 'term': 'Agenesis of Corpus Callosum'}], 'ancestors': [{'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000375', 'term': 'Aging'}], 'ancestors': [{'id': 'D048788', 'term': 'Growth and Development'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2014-07-17', 'studyFirstSubmitQcDate': '2014-10-14', 'lastUpdatePostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WPPSI-III (wechsler preschool and primary scale of intelligence) :evaluation of intellectual quotient ( questionnaire)', 'timeFrame': '3 years', 'description': 'Neurodevelopment outcome'}], 'secondaryOutcomes': [{'measure': 'Vineland adaptative behaviour scales (motricity capacity) : questionnaire', 'timeFrame': '3 years', 'description': 'Neurodevelopment outcome'}, {'measure': 'Nepsy : developmental neuropsychological assessment (capacity of coordination)', 'timeFrame': '3 years', 'description': 'Neurodevelopment outcome'}, {'measure': 'CBCL: Child Behavior Checklist (behaviour) : self administered questionnaire', 'timeFrame': '3 years', 'description': 'Neurodevelopment outcome'}, {'measure': 'Cerebral abnormalities', 'timeFrame': 'up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['agenesis', 'corpus callosum', 'prenatal diagnosis'], 'conditions': ['Agenesis of the Corpus Callosum']}, 'referencesModule': {'references': [{'pmid': '22284958', 'type': 'BACKGROUND', 'citation': 'Sotiriadis A, Makrydimas G. Neurodevelopment after prenatal diagnosis of isolated agenesis of the corpus callosum: an integrative review. Am J Obstet Gynecol. 2012 Apr;206(4):337.e1-5. doi: 10.1016/j.ajog.2011.12.024. Epub 2011 Dec 27.'}, {'pmid': '22430728', 'type': 'BACKGROUND', 'citation': 'Moutard ML, Kieffer V, Feingold J, Lewin F, Baron JM, Adamsbaum C, Gelot A, Isapof A, Kieffer F, de Villemeur TB. Isolated corpus callosum agenesis: a ten-year follow-up after prenatal diagnosis (how are the children without corpus callosum at 10 years of age?). Prenat Diagn. 2012 Mar;32(3):277-83. doi: 10.1002/pd.3824.'}, {'pmid': '12845459', 'type': 'BACKGROUND', 'citation': 'Moutard ML, Kieffer V, Feingold J, Kieffer F, Lewin F, Adamsbaum C, Gelot A, Campistol I Plana J, van Bogaert P, Andre M, Ponsot G. Agenesis of corpus callosum: prenatal diagnosis and prognosis. Childs Nerv Syst. 2003 Aug;19(7-8):471-6. doi: 10.1007/s00381-003-0781-6. Epub 2003 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum.', 'detailedDescription': 'Agenesis of the corpus callosum is the most frequent brain malformation. This anomaly may be diagnosed by ultrasound screening. In half of these prenatal cases, the anomaly seems to be isolated. In this setting, there are no prospective data concerning the development of these children, preventing any clear information to be delivered to parents. Prenatal diagnostic centers therefore face extremely variable rates of termination of pregnancies (TOP), which can reach up to 80%.\n\nThis is a multicentric prospective interventional study whose primary objective is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum.\n\nEvaluation at three years will include Intellectual Quotient (IQ) quantification using the WPPSI-III, 3rd edition of Wechsler Preschool and Primary Scale of Intelligence and evaluation of intra-hemispheric coordination using the Vineland adaptative behaviour scale.\n\nSecondary objectives will include:\n\n* Circumstances leading to the prenatal diagnosis of agenesis of the corpus callosum\n* Causes leading to termination of pregnancies\n* Determination of criteria allowing to confirm that agenesis of the corpus callosum is isolated (family history, imagery, genetics)\n\nThese results could allow to determine the optimal prenatal management of such cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women from 28 weeks of gestation\n* Complete agenesis of the corpus callosum\n* Partial agenesis of the corpus callosum\n* Abnormal corpus callosum (size, anatomy) As diagnosed by an expert ultrasound fetal brain examination.\n\nExclusion Criteria:\n\n* age \\< 18 years old\n* women who do not understand french\n* women not covered by the French social security system\n* refusal to participate'}, 'identificationModule': {'nctId': 'NCT02267161', 'acronym': 'Dacci', 'briefTitle': 'Infants With Agenesis of the Corpus Callosum', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Outcome of Infants With Prenatal Corpus Callosum Agenesis', 'orgStudyIdInfo': {'id': 'ID-RCB: 2014-A00625-42'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'neuropsycological tests', 'description': 'Psychometric scales for infants at 3 years of age', 'interventionNames': ['Other: Psychometric scales for infants at 3 years of age']}], 'interventions': [{'name': 'Psychometric scales for infants at 3 years of age', 'type': 'OTHER', 'description': 'WPPSI-III, VINELAND, CBCL, NEPSY', 'armGroupLabels': ['neuropsycological tests']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Armand Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jean-Marie Jouannic, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}