Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:19 AM
Study NCT ID:
NCT07342933
Status:
RECRUITING
Last Update Posted:
2026-01-15
First Post:
2026-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Children in Whom a Prenatal Exome Was Performed Based on Ultrasound Findings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-07-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-06', 'studyFirstSubmitDate': '2026-01-06', 'studyFirstSubmitQcDate': '2026-01-06', 'lastUpdatePostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychomotor development of the children', 'timeFrame': 'Up to 24 months', 'description': "Psychomotor development of the children based on items from the health record:\n\nThe items in the child's health record are used to:\n\n* monitor the child's normal development,\n* detect any potential delays early, and\n* reassure parents or refer them to a professional if needed.\n\nExample: If a child is not yet walking at 18 months:\n\n* this is not necessarily serious,\n* but it may lead the doctor to suggest monitoring or exercises."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amniocentesis Affecting Fetus', 'Prenatal Exome', 'Ultrasound Findings'], 'conditions': ['Amniocentesis Affecting Fetus']}, 'descriptionModule': {'briefSummary': 'Amniocentesis is a test offered to couples based on ultrasound findings during pregnancy. Currently, genetic analysis using FISH and ACPA is routinely performed. For the past four years, additional exome sequencing has been offered after two ultrasound findings, if FISH and ACPA are negative. In this study, investigators aim to review the results of this exome sequencing analysis, examine the outcomes obtained, and study the outcomes of the children after birth. Can parents be completely reassured when the exome sequencing is negative, or does this indicate that investigators are not yet sufficiently sensitive in their genetic analysis?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Child under 4 years of age having an exome sequencing performed at the Strasbourg University Hospitals following amniocentesis during pregnancy between November 2021 and September 2025.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child under 4 years of age\n* Exome sequencing performed at the Strasbourg University Hospitals (HUS) following amniocentesis during pregnancy between November 2021 and September 2025.\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Exome sequencing not performed at the Strasbourg University Hospital.\n* Lack of prenatal ultrasound information.'}, 'identificationModule': {'nctId': 'NCT07342933', 'acronym': 'ExoPré', 'briefTitle': 'Outcomes of Children in Whom a Prenatal Exome Was Performed Based on Ultrasound Findings', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Outcomes of Children in Whom a Prenatal Exome Was Performed Based on Ultrasound Findings', 'orgStudyIdInfo': {'id': '9815'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Chris MINELLA, MD', 'role': 'CONTACT', 'email': 'chris.minella@chru-strasbourg.fr', 'phone': '33 3 88 12 74 95'}, {'name': 'Chris MINELLA, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lauren GUERIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Service de Gynécologique et d'Obstétrique - CHU de Strasbourg - France", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Chris MINELLA, MD', 'role': 'CONTACT', 'email': 'chris.minella@chru-strasbourg.fr', 'phone': '33 3 88 12 74 95'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}