Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2026-03-03 @ 6:16 AM
Study NCT ID:
NCT01256606
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
2010-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prenatal Test for Fetal Aneuploidy Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000782', 'term': 'Aneuploidy'}, {'id': 'D004314', 'term': 'Down Syndrome'}], 'ancestors': [{'id': 'D002869', 'term': 'Chromosome Aberrations'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-08', 'studyFirstSubmitDate': '2010-11-22', 'studyFirstSubmitQcDate': '2010-12-07', 'lastUpdatePostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection', 'timeFrame': '24 months', 'description': 'Circulating genomic material from maternal blood will be quantified using biochemical techniques to determine the presence of fetal aneuploidy. The results obtained from analysis of circulating genomic material will be compared to the karyotype results from chorionic villus sampling or amniocentesis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aneuploidy', 'Trisomy 21']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women planning to undergo chorionic villus sampling or amniocentesis for fetal genetic evaluation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is 18yrs or older\n* Subject has a singleton pregnancy\n* Subject is planning to undergo chorionic villus sampling (CVS) and/or amniocentesis with current pregnancy\n* Subject is able to provide consent\n\nExclusion Criteria:\n\n* Subject is pregnant with more than one fetus\n* Subject (mother) has known aneuploidy\n* Subject has active malignancy requiring major surgery or systemic chemotherapy or has a history of metastatic cancer.\n* Subject has already undergone CVS or amniocentesis during current pregnancy prior to study enrollment.'}, 'identificationModule': {'nctId': 'NCT01256606', 'briefTitle': 'Prenatal Test for Fetal Aneuploidy Detection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Roche Sequencing Solutions'}, 'officialTitle': 'Investigational Study of a Prenatal Diagnostic Test for Fetal Aneuploidy', 'orgStudyIdInfo': {'id': 'TT001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Positive for fetal aneuploidy'}, {'label': 'Negative for fetal aneuploidy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'East Bay Perinatal Medical Associates', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Prenatal Diagnosis of Northern California', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California - San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94122', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California - San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Perinatal Consultants', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Ken Song, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ariosa Diagnostics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roche Sequencing Solutions', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}