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NCT07643896
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: Pregnant Individuals, Aneuploidy, Down Syndrome (Trisomy 21), 22q11.2 Deletion Syndrome, Trisomy 13, Trisomy 18, Sex Chromosome Abnormalities
Sex: Female
Healthy volunteers: No
Enrollment: 1000
Sponsor: BillionToOne Inc.
Location: Valley Perinatal Services Phoenix Arizona
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 Criteria
Inclusion Criteria:
* pregnant individuals between 10 and 20 weeks of gestation
* singleton gestation
Exclusion Criteria:
\- active cancer
Source: ClinicalTrials.gov (NCT07643896). StuddyBuddy aggregates publicly available trial information.
