[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07643896":3,"trial-entities:NCT07643896":161,"trial-summary:NCT07643896":173},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":26,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":35,"interventions":38,"primary_outcomes":39,"secondary_outcomes":47,"sex":48,"minimum_age":33,"maximum_age":33,"healthy_volunteers":15,"eligibility_criteria":49,"std_ages":55,"locations":59,"central_contacts":151,"overall_officials":156,"references":159,"see_also_links":160},"NCT07643896","BTO-IRB-014","The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment","ADVANCE Study: Assay Development and Validation for Pre-Natal and Obstetric Conditions","RECRUITING","2028-06","2026-06","2026-06-12","2026-01-10","BillionToOne Inc.","INDUSTRY",false,"The goal of the ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) study is to compare the concordance of results of a novel non-invasive circulating fetal cell (CFC) assay to the results of prenatal invasive diagnostic testing or postnatal genetic and clinical diagnosis of the resulting neonate. This is a prospective study of pregnant individuals.","BillionToOne Inc. is conducting a large prospective study to evaluate the performance of a non-invasive circulating fetal cell (CFC) assay. Circulating fetal cells, rare, intact trophoblast cells of placental origin present in maternal blood, offer a unique opportunity to directly analyze fetal genetic material without the need for invasive procedures. These cells are most abundant during the first trimester of pregnancy.\n\nBuilding on this biology, the investigators developed a circulating fetal cell assay (UNITY Confirm) that isolates fetal-derived placenta cells from maternal blood and performs single-cell genomic analysis to assess chromosomal copy number. By combining cell-type-specific markers and genotyping to distinguish fetal from maternal cells, this approach enables direct evaluation of fetal chromosomal status, unlike cfDNA methods that rely on analysis of mixed DNA fragments.\n\nThis prospective study enrolls pregnant individuals between 10 and 20 weeks of gestation with singleton pregnancies and aims to include over 1,000 participants. CFC testing results are compared to prenatal or postnatal diagnostic outcomes.",[19,20,21,22,23,24,25],"Pregnant Individuals","Aneuploidy","Down Syndrome (Trisomy 21)","22q11.2 Deletion Syndrome","Trisomy 13","Trisomy 18","Sex Chromosome Abnormalities",[27,28,29,30,31],"pregnant","aneuploidy","NIPT","NIPS","circulating fetal cell","OBSERVATIONAL",null,[],{"count":36,"type":37},1000,"ESTIMATED",[],[40,44],{"measure":41,"description":42,"timeFrame":43},"Concordance","CFC results will be compared with prenatal diagnostic testing results, CVS, amniocentesis, products of conception, when available, and postnatal diagnostic testing.","From enrollment and up to 12 months following enrollment",{"measure":45,"description":46,"timeFrame":43},"Concordance with the accepted method of diagnosis","CFC results will be compared with prenatal diagnostic testing results, CVS, amniocentesis, products of conception, when available, and postnatal diagnostic testing. Results are considered concordant when CFC findings are consistent with the known or fetal or neonatal diagnosis.",[],"FEMALE",{"inclusion":50,"exclusion":53,"raw_text":54},[51,52],"pregnant individuals between 10 and 20 weeks of gestation","singleton gestation",[],"Inclusion Criteria:\n\n* pregnant individuals between 10 and 20 weeks of gestation\n* singleton gestation\n\nExclusion Criteria:\n\n\\- active cancer",[56,57,58],"CHILD","ADULT","OLDER_ADULT",[60,78,92,107,122,137],{"facility":61,"status":8,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":75},"Valley Perinatal Services","Phoenix","Arizona","85004","United States",[67,72],{"name":68,"role":69,"phone":70,"email":71},"Research Department","CONTACT","480-756-6000","research@valleyperinatal.com",{"name":73,"role":74},"Nayo Williams, MD","PRINCIPAL_INVESTIGATOR",{"lat":76,"lon":77},33.44838,-112.07404,{"facility":79,"status":8,"city":80,"state":81,"zip":82,"country":65,"contacts":83,"geoPoint":89},"San Gabriel Valley Perinatal Medical Group","West Covina","California","91710",[84,88],{"name":85,"role":69,"phone":86,"email":87},"Richard Burwick, MD","(626) 337-4425","dr.burwick@sgvpmg.com",{"name":85,"role":74},{"lat":90,"lon":91},34.06862,-117.93895,{"facility":93,"status":8,"city":94,"state":95,"zip":96,"country":65,"contacts":97,"geoPoint":104},"Sarasota Memorial Health Care System","Sarasota","Florida","34239",[98,102],{"name":99,"role":69,"phone":100,"email":101},"Scarleth Andino-Funez, BSN, RN","941-917-2627","Scarleth-AndinoFunez@smh.com",{"name":103,"role":74},"Larry C Matsumoto, MD",{"lat":105,"lon":106},27.33643,-82.53065,{"facility":108,"status":8,"city":109,"state":110,"zip":111,"country":65,"contacts":112,"geoPoint":119},"Pediatrix Medical Group of Georgia","Atlanta","Georgia","30342",[113,117],{"name":114,"role":69,"phone":115,"email":116},"Deena Yowler, NP, CNM","404-847-1592","deena.yowler@pediatrix.com",{"name":118,"role":74},"Gretchen Koontz, MD",{"lat":120,"lon":121},33.749,-84.38798,{"facility":123,"status":8,"city":124,"state":125,"zip":126,"country":65,"contacts":127,"geoPoint":134},"Woman's Hospital","Baton Rouge","Louisiana","70817",[128,132],{"name":129,"role":69,"phone":130,"email":131},"Bri Jones, MPH","225-927-1300","Briasha.Jones@womans.org",{"name":133,"role":74},"Elizabeth Sutton, PhD",{"lat":135,"lon":136},30.44332,-91.18747,{"facility":138,"status":8,"city":139,"state":140,"zip":141,"country":65,"contacts":142,"geoPoint":148},"Pediatrix Medical Group","Houston","Texas","773339",[143,147],{"name":144,"role":69,"phone":145,"email":146},"Olaide Ashimi Balogun, MD","346-616-2777","olaide.ashimibalogun@pediatrix.com",{"name":144,"role":69},{"lat":149,"lon":150},29.76328,-95.36327,[152],{"name":153,"role":69,"phone":154,"email":155},"Shannon O'Rourke Senior Research Manager, MS, CGC","650-460-2551","unityregistry@billiontoone.com",[157],{"name":158,"affiliation":13,"role":74},"Julia Wynn, MS, MS, CGC",[],[],{"nct_id":4,"conditions":162,"biomarkers":167},[22,163,20,164,165,25,166],"5p13 microduplication syndrome","Down Syndrome","Pregnancy","Trisomy 18 Syndrome",[168,169,170,171,172],"18q","22q11.2","Chromosome 13","Chromosome 21","Sex Chromosome",{"nct_id":4,"found":15,"summary":33,"prompt_version":33}]