Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT04488393
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2020-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Performance of NIPT in Multiple Gestation Pregnancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-05', 'studyFirstSubmitDate': '2020-07-22', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of sensitivity of NIPT detection of trisomy 21 among a population of women with twin gestations.', 'timeFrame': 'time from maternal blood draw to delivery'}, {'measure': 'Determination of specificity of NIPT detection of trisomy 21 among a population of women with twin gestations.', 'timeFrame': 'time from maternal blood draw to delivery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trisomy 21 in Fetus']}, 'referencesModule': {'references': [{'pmid': '39260415', 'type': 'DERIVED', 'citation': 'Siegel MR, James K, Bromley B, Koelper NC, Chasen ST, Griffin L, Roman AS, Limaye M, Ranzini A, Clifford C, Biggio JR, Subramaniam A, Seasely AR, Page JM, Nicholas SS, Idler J, Rao R, Shree R, McLennan G, Dugoff L; Twin cfDNA Study Consortium. First-Trimester Cell-Free DNA Fetal Fraction and Birth Weight in Twin Pregnancies. Am J Perinatol. 2025 Apr;42(5):605-611. doi: 10.1055/a-2413-2353. Epub 2024 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'This study plans to evaluate the clinical performance of the MaterniT21 PLUS and/or GENOME Laboratory Developed Test, in the detection of fetal trisomy 21 in circulating cell-free DNA extracted from maternal blood samples obtained from women pregnant with a twin gestation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The Study Population will consist of women 18 years of age and older who underwent testing with a Sequenom NIPT, were pregnant with a multiple gestation at the time of testing and whose pregnancies should have outcome based upon gestational age at the time of testing.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subject pregnant with a multiple gestation and received NIPT from Sequenom Laboratories;\n* subject was 18 or older at the time of NIPT\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04488393', 'briefTitle': 'Clinical Performance of NIPT in Multiple Gestation Pregnancies', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Clinical Performance of NIPT (Noninvasive Prenatal Testing) in Multiple Gestation Pregnancies (SCMM-T21-110)', 'orgStudyIdInfo': {'id': 'SCMM-T21-110'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnancies with multiple gestations', 'interventionNames': ['Device: MaterniT21 PLUS and GENOME Laboratory-Developed Tests']}], 'interventions': [{'name': 'MaterniT21 PLUS and GENOME Laboratory-Developed Tests', 'type': 'DEVICE', 'description': 'Both the MaterniT21 PLUS and GENOME are intended for use as laboratory developed test that analyze ccfDNA extracted from a maternal blood sample utilizing Massively Parallel Sequencing (MPS) technology.', 'armGroupLabels': ['Pregnancies with multiple gestations']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sequenom, Inc/Laboratory Corporation of America Holdings', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Obstetrics and Gynecology', 'investigatorFullName': 'Lorraine Dugoff', 'investigatorAffiliation': 'University of Pennsylvania'}}}}