Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-02-05 @ 7:36 AM
Study NCT ID:
NCT03201666
Status:
UNKNOWN
Last Update Posted:
2017-06-29
First Post:
2017-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Karyotyping, CMA and NIPT for Prenatal Diagnosing Chromosomal Anomalies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Sample1.maternal peripheral blood，which used for extracted fetal free DNA for NIPT examination Sample2.amniotic fluid, which used for karyotyping and CMA analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-28', 'studyFirstSubmitDate': '2017-06-26', 'studyFirstSubmitQcDate': '2017-06-26', 'lastUpdatePostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'accuracy of NIPT for prenatal diagnosing chromosomal anomalies', 'timeFrame': 'July,2016-July, 2017', 'description': 'sensitive, false negative rate, and false positive rate of NIPT compared with CMA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prenatal diagnosis', 'non-invasive prenatal tests', 'chromosome microarray analysis'], 'conditions': ['Prenatal Diagnosis']}, 'descriptionModule': {'briefSummary': 'This diagnostic test is aimed to compare the Karyotyping, CMA and NIPT for prenatal diagnosing chromosomal anomalies. Pregnant women who needed prenatal genetic diagnosis meted the study criterion; fetal amniotic fluid was regular examined by Karyotyping and CMA, and maternal peripheral blood was collected for NIPT detecting. And the CMA result as a golden standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing chromosomal anomalies.', 'detailedDescription': 'Aim: to compare the Karyotyping, CMA and NIPT for prenatal diagnosing chromosomal anomalies.\n\nDesign: diagnostic test Set: Prenatal diagnosis center of Taizhou City Study population: The Pregnant women who needed amniocenteses for prenatal genetic diagnosis were recruited.\n\nMethods: amniotic fluid was regular examined by Karyotyping and CMA, and maternal peripheral blood was used for collected for NIPT detecting.\n\nStatistic: CMA result as a golden standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing chromosomal anomalies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women who needed amniocenteses were recruited during the study period', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pregnant women who needed amniocenteses were recruited during the study period, include high risk for serum screening, aged over 35 years and ultrasound abnormal.\n2. only singleton were included\n\nExclusion Criteria:\n\n1. women who met the contraindication for invasive procedure as : threaten abortion, acute infectious disease.\n2. Women who unfitted for NIPT analysis include multiple, history of allogeneic blood cell transfusion.'}, 'identificationModule': {'nctId': 'NCT03201666', 'briefTitle': 'Comparison of Karyotyping, CMA and NIPT for Prenatal Diagnosing Chromosomal Anomalies', 'organization': {'class': 'OTHER', 'fullName': 'Taizhou Hospital'}, 'officialTitle': 'Comparison of Karyotyping, CMA and NIPT for Prenatal Diagnosing Chromosomal Anomalies', 'orgStudyIdInfo': {'id': 'TZ201607'}}, 'contactsLocationsModule': {'locations': [{'zip': '317000', 'city': 'Taizhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'YiYang Zhu, MD', 'role': 'CONTACT', 'email': 'zuyy@tzhospital.com', 'phone': '+8613819630569'}], 'facility': 'Taizhou Hospital of Zhejiang province', 'geoPoint': {'lat': 28.66266, 'lon': 121.43312}}], 'centralContacts': [{'name': 'YiYang Zhu, MD', 'role': 'CONTACT', 'email': 'zuyy@tzhospital.com', 'phone': '+8613819630569'}], 'overallOfficials': [{'name': 'YiYang Zhu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'prenatal doagnosis center of taizhou city'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'YiYang Zhu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director,Clinical dean of Prenatal Diagnosis Center', 'investigatorFullName': 'YiYang Zhu', 'investigatorAffiliation': 'Taizhou Hospital'}}}}