ADVANCE Study: Assay Development and Validation for Pre-Natal and Obstetric Conditions
Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:
• pregnant individuals between 10 and 20 weeks of gestation
• singleton gestation
Locations
United States
Arizona
Valley Perinatal Services
RECRUITING
Phoenix
California
San Gabriel Valley Perinatal Medical Group
RECRUITING
West Covina
Florida
Sarasota Memorial Health Care System
RECRUITING
Sarasota
Georgia
Pediatrix Medical Group of Georgia
RECRUITING
Atlanta
Louisiana
Woman's Hospital
RECRUITING
Baton Rouge
Texas
Pediatrix Medical Group
RECRUITING
Houston
Contact Information
Primary
Shannon O'Rourke Senior Research Manager, MS, CGC
unityregistry@billiontoone.com
650-460-2551
Time Frame
Start Date: 2026-01-10
Estimated Completion Date: 2028-06
Participants
Target number of participants: 1000
Treatments
High Risk
Pregnant individuals between 10 and 20 weeks of gestation with singleton pregnancies and who have a clinical indication for CFC testing, such as high-risk cfDNA results for common aneuploidies, copy number variants including 22q11.2, or sex chromosome aneuploidies
General Risk
Pregnant individuals between 10 and 20 weeks of gestation with singleton pregnancies (excluding gestational surrogates) who do not have a clinical indication for CFC and are undergoing prenatal diagnostic testing
Related Therapeutic Areas
Sponsors
Leads: BillionToOne Inc.