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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
BillionToOne Inc.
Study ID
NCT07643896
Status
Recruiting
Apply to this trial

Conditions

  • 22q11.2 Deletion Syndrome
  • Aneuploidy
  • Down Syndrome (Trisomy 21)
  • Pregnant Individuals
  • Sex Chromosome Abnormalities
  • Trisomy 13
  • Trisomy 18

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jan 10, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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

Primary Outcome Measure

Concordance [ Time Frame: From enrollment and up to 12 months following enrollment ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Valley Perinatal ServicesPhoenixArizona85004
Research Department
[email protected]
480-756-6000
Nayo Williams, MD (PRINCIPAL_INVESTIGATOR)
San Gabriel Valley Perinatal Medical GroupWest CovinaCalifornia91710
Richard Burwick, MD
[email protected]
(626) 337-4425
Richard Burwick, MD (PRINCIPAL_INVESTIGATOR)
Sarasota Memorial Health Care SystemSarasotaFlorida34239
Scarleth Andino-Funez, BSN, RN
[email protected]
941-917-2627
Larry C Matsumoto, MD (PRINCIPAL_INVESTIGATOR)
Pediatrix Medical Group of GeorgiaAtlantaGeorgia30342
Deena Yowler, NP, CNM
[email protected]
404-847-1592
Gretchen Koontz, MD (PRINCIPAL_INVESTIGATOR)
Woman's HospitalBaton RougeLouisiana70817
Bri Jones, MPH
[email protected]
225-927-1300
Elizabeth Sutton, PhD (PRINCIPAL_INVESTIGATOR)
Pediatrix Medical GroupHoustonTexas773339
Olaide Ashimi Balogun, MD
[email protected]
346-616-2777
Olaide Ashimi Balogun, MD

Find similar trials in Phoenix, AZ

By research site
Valley Perinatal Services· Phoenix, AZSan Gabriel Valley Perinatal Medical Group· West Covina, CASarasota Memorial Health Care System· Sarasota, FLPediatrix Medical Group of Georgia· Atlanta, GAWoman's Hospital· Baton Rouge, LAPediatrix Medical Group· Houston, TX

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