Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-27 @ 4:06 PM
Study NCT ID:
NCT05023161
Status:
UNKNOWN
Last Update Posted:
2023-11-08
First Post:
2021-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Placental Chromosome Exploration of Intrauterine Growth Restriction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005317', 'term': 'Fetal Growth Retardation'}, {'id': 'D014314', 'term': 'Trisomy'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000782', 'term': 'Aneuploidy'}, {'id': 'D002869', 'term': 'Chromosome Aberrations'}, {'id': 'D058674', 'term': 'Chromosome Duplication'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-10-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2021-08-20', 'studyFirstSubmitQcDate': '2021-08-20', 'lastUpdatePostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the presence or absence of chromosomal abnormality in the plasma sample. studied.', 'timeFrame': 'Inclusion date', 'description': 'The result will be expressed in presence or absence of chromosomal abnormality such as trisomy, monosomy, deletion or duplication. The result will be compared with the fetal chromosome analysis carried out concomitantly on liquid amniotic as part of the treatment: if the analysis on Liquid Amniotic shows the same anomaly, it means that it is a fetal abnormality, if the Liquid Amniotic test is normal, it means that it is most likely an abnormality placental chromosome.'}], 'secondaryOutcomes': [{'measure': 'Determine the proportion of chromosomal placental etiology in Intrauterine Growth Restriction.', 'timeFrame': 'Inclusion date', 'description': "Proportion will be described in terms of percentage counts and 95% confidence interval depending on the test Fisher's exact (p \\<0.05)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non Invasive Prenatal Testing', 'cell- free DNA', 'trisomy', 'placenta confined mosaic'], 'conditions': ['Fetal Growth Retardation']}, 'descriptionModule': {'briefSummary': 'The objective of this project is the non-invasive prenatal detection of placenta-limited aneuploidies, in patients whose fetuses have a intrauterine growth restriction below 3rd percentile, in parallel with an amniocentesis.\n\nThis study will allow the chromosomal study of the placenta in pregnant women whose genetic prenatal diagnosis, made by amniocentesis, does not allow exploring the placental causes of fetal RCIU.', 'detailedDescription': 'Placental chromosomal aneuploidies will be detected by high-throughput whole genome sequencing of non-cellular DNA present in maternal plasma during pregnancy.\n\nThe study of the cfDNA will be carried out from a blood sample with the automated solution VERISEQ NIPT (Illumina) using the software illumina VeriSeq v2, allowing the detection of all chromosomal abnormalities.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient having a fetus with IUGR diagnosis below the 3rd percentile (after reference medical ultrasound)', 'genderDescription': 'having a fetus with IUGR diagnosis below the 3rd percentile (after reference medical ultrasound)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years old,\n* treated in the DDIANE fetal medicine centre at the Bordeaux University Hospital,\n* having a fetus with IUGR diagnosis below the 3rd percentile (after reference medical ultrasound),\n* from 16 weeks of amenorrhea or more,\n* accepting an Invasive Prenatal Diagnosis by amniocentesis with array comparative genomic hybridization\n\nExclusion Criteria:\n\nChildbearing women who:\n\n* do not accept a non-invasive prenatal diagnosis (amniocentesis)\n* have a fetus with non-isolated IUGR (associated with other ultrasound signs)\n* do not consent to participate in the research protocol'}, 'identificationModule': {'nctId': 'NCT05023161', 'acronym': 'DPNI-RCIU', 'briefTitle': 'Non-invasive Placental Chromosome Exploration of Intrauterine Growth Restriction', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Non-invasive Prenatal Testing of Placental Chromosomal Abnormalities in Fetus With Intrauterine Growth Restriction', 'orgStudyIdInfo': {'id': 'CHUBX 2021/12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient having a fetus with intra-uterine growth restriction diagnosis below the 3rd percentile', 'interventionNames': ['Biological: Blood samples']}], 'interventions': [{'name': 'Blood samples', 'type': 'BIOLOGICAL', 'description': 'Performed a 10 ml blood sample in each of the 200 patients included.', 'armGroupLabels': ['Patient having a fetus with intra-uterine growth restriction diagnosis below the 3rd percentile']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Caroline THAMBO', 'role': 'CONTACT', 'email': 'caroline.rooryck-thambo@chu-bordeaux.fr', 'phone': '05 56 79 59 52'}], 'facility': 'Centre Hospitalier Universitaire de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '92140', 'city': 'Clamart', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandre VIVANTI, MD', 'role': 'CONTACT', 'email': 'alexandre.vivanti@aphp.fr', 'phone': '+331.45.37.44.41'}, {'name': 'Alexandre VIVANTI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Antoine Béclère', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe VAYSSIERE, PROF', 'role': 'CONTACT', 'email': 'vayssiere.c@chu-toulouse.fr', 'phone': '+335 67 77 12 16'}, {'name': 'Christophe VAYSSIERE, PROF', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Caroline THAMBO', 'role': 'CONTACT', 'email': 'caroline.rooryck-thambo@chu-bordeaux.fr', 'phone': '05 56 79 59 52'}, {'name': 'Virginie RACLET', 'role': 'CONTACT', 'email': 'virginie.raclet@chu-bordeaux.fr', 'phone': '05 56 79 59 52'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}