RecruitingNCT07643896

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

Sponsor

BillionToOne Inc.

Enrollment

1,000 participants

Start Date

Jan 10, 2026

Study Type

OBSERVATIONAL

Conditions

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

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

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with 22q11.2 deletion syndrome, aneuploidy, and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include women.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(6)

Valley Perinatal Services

Phoenix, Arizona, United States

San Gabriel Valley Perinatal Medical Group

West Covina, California, United States

Sarasota Memorial Health Care System

Sarasota, Florida, United States

Pediatrix Medical Group of Georgia

Atlanta, Georgia, United States

Woman's Hospital

Baton Rouge, Louisiana, United States

Pediatrix Medical Group

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07643896

Related Trials

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

Conditions

Summary

Eligibility

Plain Language Summary

Locations(6)

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