Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-02-20 @ 1:43 PM
Study NCT ID:
NCT03635359
Status:
UNKNOWN
Last Update Posted:
2018-08-17
First Post:
2018-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automated Screen for Fetal Aneuploidy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}, {'id': 'D014314', 'term': 'Trisomy'}, {'id': 'D000782', 'term': 'Aneuploidy'}], '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': 'D002869', 'term': 'Chromosome Aberrations'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D058674', 'term': 'Chromosome Duplication'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-14', 'studyFirstSubmitDate': '2018-08-14', 'studyFirstSubmitQcDate': '2018-08-14', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of blood test to fetal karyotype', 'timeFrame': '21 months', 'description': 'Maternal plasma cell-free DNA will be analyzed to determine copy number of specific chromosomes and compared to the fetal karyotype as obtained through invasive diagnostic testing of the fetus.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fetal', 'screening test', 'trisomy', 'aneuploidy', 'copy number variant'], 'conditions': ['Trisomy 21 and Other Fetal Aneuploidy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop and evaluate a blood test and automated microfluidic test platform for the prenatal screening of fetal aneuploidy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant with singleton or twin pregnancy and having and indicated physician prescribed prenatal diagnostic procedure.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is at least 18 years old and can provide informed consent;\n2. Subject has a viable singleton or twin pregnancy;\n3. Subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the study blood draw;\n4. Subject is planning to undergo chorionic villus sampling and/or amniocentesis for the purpose of genetic analysis of the fetus because of a suspected fetal chromosomal anomaly based on cell-free DNA test results, standard serum screening result, or fetal ultrasound abnormality.\n5. OR the subject has already undergone chorionic villus sampling and/or amniocentesis and is known to have a fetus with a chromosomal abnormality confirmed by genetic analysis.\n\nExclusion Criteria:\n\n1. Subject (the mother) has known aneuploidy;\n2. Subject is pregnant with more than two fetuses or has had sonographic evidence of three or more gestational sacs at any time during pregnancy;\n3. Subject has a fetal demise (including natural or elective reduction) identified prior to consent;\n4. Subject has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant.'}, 'identificationModule': {'nctId': 'NCT03635359', 'acronym': 'FAST1', 'briefTitle': 'Automated Screen for Fetal Aneuploidy', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioCeryx'}, 'officialTitle': 'Fluidic Automated Screening for Trisomy Study I', 'orgStudyIdInfo': {'id': 'BCX 120'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'positive for fetal aneuploidy', 'interventionNames': ['Diagnostic Test: blood test']}, {'label': 'negative for fetal aneuploidy', 'interventionNames': ['Diagnostic Test: blood test']}], 'interventions': [{'name': 'blood test', 'type': 'DIAGNOSTIC_TEST', 'description': 'analysis of cell-free DNA in maternal plasma', 'armGroupLabels': ['negative for fetal aneuploidy', 'positive for fetal aneuploidy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sydney', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'University Hospital Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Vancouver', 'country': 'Canada', 'facility': 'University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital CUF Descobertas', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario Virgen de la Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Thomas J Musci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BioCeryx'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioCeryx', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Brugmann University Hospital', 'class': 'OTHER'}, {'name': 'University of British Columbia', 'class': 'OTHER'}, {'name': 'Royal Prince Alfred Hospital, Sydney, Australia', 'class': 'OTHER'}, {'name': 'Hospital Universitario Virgen de la Arrixaca', 'class': 'OTHER'}, {'name': 'Hospital CUF Descobertas, Lisbon, Portugal', 'class': 'UNKNOWN'}, {'name': 'University College London Hospitals', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}