ADVANCE Study Evaluating a New Non-Invasive Blood Test to Detect Fetal Genetic Conditions in Pregnant Women from 10 to 20 Weeks

What this Trial Is About

Researchers are evaluating a new non-invasive blood test called a circulating fetal cell CFC assay to assess fetal genetic conditions in pregnant individuals. This prospective study focuses on pregnant individuals between 10 and 20 weeks of gestation with singleton pregnancies. The CFC assay aims to detect fetal chromosomal abnormalities by isolating fetal cells from maternal blood, offering an alternative to invasive diagnostic procedures and current DNA fragment analysis methods. Participants include two groups those with clinical indications for CFC testing such as high-risk cell-free DNA results for common aneuploidies and those without clinical indications undergoing prenatal diagnostic testing. The study compares CFC assay results with prenatal invasive diagnostic testing or postnatal genetic and clinical diagnoses. Enrollment targets over 1,000 participants, and testing is conducted during the first trimester when fetal cells are most abundant. During the study, participants provide blood samples for the CFC assay between 10 and 20 weeks of pregnancy. The research team monitors concordance between the CFC test results and accepted diagnostic methods from enrollment up to 12 months postpartum. The study involves collecting clinical data and follow-up information to evaluate the accuracy of this non-invasive fetal risk assessment. Participation spans from early pregnancy through one year after enrollment.

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