Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-01 @ 12:22 PM
Study NCT ID:
NCT00770458
Status:
COMPLETED
Last Update Posted:
2010-01-06
First Post:
2008-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
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_WITHOUT_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-04', 'studyFirstSubmitDate': '2008-10-08', 'studyFirstSubmitQcDate': '2008-10-09', 'lastUpdatePostDateStruct': {'date': '2010-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare investigational assay results for Down Syndrome to standard of care results.', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Down Syndrome'], 'conditions': ['Down Syndrome (Trisomy 21)', 'Edwards Syndrome (Trisomy 18)', 'Patau Syndrome (Trisomy 13)', 'Turner Syndrome']}, 'descriptionModule': {'briefSummary': 'Validate that circulating cell free fetal nucleic acid can be used to identify a direct marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than surrogate markers.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Fetal care and genetic counseling patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is female\n* Subject is pregnant\n* Subject is high risk aneuploid patient undergoing genetic counseling, unltrasound screening, amniocentesis and/or CVS procedure\n* Subject is willing to provide blood specimen\n\nExclusion Criteria:\n\n* Subject is not pregnant\n* Subject is not willing to provide blood specimen\n* Subject is not haveing aneuploid screening'}, 'identificationModule': {'nctId': 'NCT00770458', 'briefTitle': 'Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sequenom, Inc.'}, 'officialTitle': 'Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker', 'orgStudyIdInfo': {'id': 'SQNM-Trisomy21-0100'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women', 'description': 'Pregnant women that will undergo standard of care procedures to evaluate fetus for Down Syndrome'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Fetal Care & Genetics Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Perinatal Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '95008', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Obstetrix Medical Group of San Jose', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Obstetrix Medical Group of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Women & Infants', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'A.R.U.P.', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Obstetrix Medical Group of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Allan Bombard, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sequenom, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sequenom, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Elizabeth Dragon / Sr. VP Research & Development', 'oldOrganization': 'Sequenom, Inc.'}}}}