Prenatal Test for Fetal Aneuploidy Detection

Roche Diagnostics

Status: Completed

Conditions: Aneuploidy; Trisomy 21

Study type: Observational

Funder types: Industry

Identifiers

NCT01256606

TT001

Details and patient eligibility

About

The purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy.

Enrollment: 4,000 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is 18yrs or older
• Subject has a singleton pregnancy
• Subject is planning to undergo chorionic villus sampling (CVS) and/or amniocentesis with current pregnancy
• Subject is able to provide consent

Exclusion criteria

• Subject is pregnant with more than one fetus
• Subject (mother) has known aneuploidy
• Subject has active malignancy requiring major surgery or systemic chemotherapy or has a history of metastatic cancer.
• Subject has already undergone CVS or amniocentesis during current pregnancy prior to study enrollment.

Trial design

4,000 participants in 2 patient groups

Positive for fetal aneuploidy

Negative for fetal aneuploidy