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

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

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

AgeNot listed

SponsorBillionToOne Inc.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

pregnant individuals between 10 and 20 weeks of gestation

singleton gestation

Disqualifiers

None

Trial population

pregnant individuals between 10 and 20 weeks of gestation with singleton pregnancies

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants

are grouped into 2 trial groups

Group A: High Risk

Group B: General Risk

Trial outcomes

Primary outcomes

Concordance

CFC results will be compared with prenatal diagnostic testing results, CVS, amniocentesis, products of conception, when available, and postnatal diagnostic testing.

Time frame

From enrollment and up to 12 months following enrollment

Concordance with the accepted method of diagnosis

CFC results will be compared with prenatal diagnostic testing results, CVS, amniocentesis, products of conception, when available, and postnatal diagnostic testing. Results are considered concordant when CFC findings are consistent with the known or fetal or neonatal diagnosis.

Time frame

From enrollment and up to 12 months following enrollment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BillionToOne Inc.

Lead sponsor

Source ClinicalTrials.gov

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