Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-04-05 @ 8:22 AM
Study NCT ID:
NCT01663350
Status:
COMPLETED
Last Update Posted:
2013-07-16
First Post:
2012-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Aneuploidy Risk Evaluations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}, {'id': 'D000073842', 'term': 'Trisomy 18 Syndrome'}, {'id': 'D000073839', 'term': 'Trisomy 13 Syndrome'}, {'id': 'D014424', 'term': 'Turner Syndrome'}], 'ancestors': [{'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'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006059', 'term': 'Gonadal Dysgenesis'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D058533', 'term': 'Sex Chromosome Disorders of Sex Development'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D025064', 'term': 'Sex Chromosome Disorders'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2013-07-12', 'studyFirstSubmitDate': '2012-07-31', 'studyFirstSubmitQcDate': '2012-08-08', 'lastUpdatePostDateStruct': {'date': '2013-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care).', 'timeFrame': '12 months', 'description': 'The primary outcome of this study is the false positive rate of fetal aneuploidy detection for chromosome 21, 18, and 13 by the Verinata Health Prenatal Aneuploidy Test and screen positive rate for fetal trisomy (T21) and trisomy (T18) by conventional prenatal screening methods. Birth outcomes, or karyotype if available, will be used as the reference standard.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pregnancy', 'Down Syndrome', 'Edwards Syndrome', 'Patau Syndrome', 'Turners Syndrome']}, 'referencesModule': {'references': [{'pmid': '24571752', 'type': 'DERIVED', 'citation': 'Bianchi DW, Parker RL, Wentworth J, Madankumar R, Saffer C, Das AF, Craig JA, Chudova DI, Devers PL, Jones KW, Oliver K, Rava RP, Sehnert AJ; CARE Study Group. DNA sequencing versus standard prenatal aneuploidy screening. N Engl J Med. 2014 Feb 27;370(9):799-808. doi: 10.1056/NEJMoa1311037.'}]}, 'descriptionModule': {'briefSummary': "This is a prospective, multi-center observational study designed to compare the test results of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening for fetal chromosome abnormalities in 'all-risk' pregnancies."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is comprised of pregnant women at least 18 years of age, who meet the study eligibility criteria. Women who plan or have already completed prenatal screening for fetal aneuploidy during first and/or second trimester, will be recruited from approved participating clinical centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older at enrollment\n* Clinically confirmed pregnancy\n* Gestational age ≥8 weeks, 0 days\n* Planned or completed prenatal serum screening\\* (drawn during 1st and/or 2nd trimester)\n* Pregnancy records accessible and available for data collection (e.g., results from screening, ultrasound examinations, invasive prenatal procedures if performed, and newborn hospital discharge exam)\n* Able to provide consent for participation using language appropriate forms\n\nExclusion Criteria:\n\n* Invasive prenatal procedure (amniocentesis or CVS) performed within 2 weeks prior to enrollment\n* Prenatal screening determination by Nuchal Translucency (NT) measurement only'}, 'identificationModule': {'nctId': 'NCT01663350', 'acronym': 'CARE', 'briefTitle': 'Comparison of Aneuploidy Risk Evaluations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Verinata Health, Inc.'}, 'officialTitle': "Performance of the Verinata Health Prenatal Aneuploidy Test Compared to Current Fetal Aneuploidy Screening Results and Pregnancy Outcomes in an 'All-Risk' Population", 'orgStudyIdInfo': {'id': 'VER-0007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All-risk pregnant women', 'description': 'All-risk pregnancies undergoing conventional forms of prenatal screening'}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'West Coast OB/GYN', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'AD Williams Laboratory', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Prentice Women's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Desert Perinatal Associates', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': "St. Peter's University Hospital", 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Virtua Perinatology Associates of Voorhees', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northshore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Winthrop University Hospital', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Jewish Medical Center', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Jacobi Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lyndhurst Clinical Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lyndhurst Clinical Research', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Maternal Fetal Medicine', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Mayfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'MacDonald Clinical Research Unit', 'geoPoint': {'lat': 41.51922, 'lon': -81.4579}}, {'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Network Office of Research and Innovation Lehigh Valley Health Network', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'South Carolina Clinical Research', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Hospital Systems', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Jackson Clinic', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Practice Research Organization', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Eastern Virginia Medical School', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Group for Women', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Amy J Sehnert, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Verinata Health, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Verinata Health, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}