Study of Vanadis® NIPT for Non-invasive Prenatal Screening of Trisomies (T21, T18 and T13)

Perkin Elmer

Status: Unknown

Conditions: Trisomy 13; Trisomy 18; Trisomy 21

Treatments: Other: Vanadis NIPT system

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03559374

F01-16013

Details and patient eligibility

About

This study will assess the feasibility of Vanadis NIPT for screening of T21, T18 and T13. The results obtained from Vanadis NIPT will be compared with the study site's current prenatal screening methods. The primary objectives are: 1) To assess the feasibility of Vanadis NIPT for screening of T21, T18 and T13 in the maternal healthcare setting, 2) To assess preliminary performance of Vanadis NIPT for screening of T21 in comparison to site's routine screening methods i.e. combined and integrated tests, and 3) To evaluate preliminary cost effectiveness of Vanadis NIPT use in different models. The secondary objective is to assess the feasibility of Vanadis NIPT regarding determination of fetal sex.

Enrollment: 1,200 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• between the age of 18 and 55 years (inclusive)
• ≥ 10+0 weeks gestation

Exclusion criteria

• Pregnant woman undergoing amniocentesis without any screening test result
• Pregnant woman with previous severe hypotension episodes or other conditions that may complicate the blood sampling
• Known maternal aneuploidy
• Known maternal cancer
• Invasive test (chorionic villus sampling or amniocentesis) performed before blood sampling for NIPT

Trial design

1,200 participants in 1 patient group

Pregnant women

Description:

Consenting women will provide samples to be tested with Vanadis NIPT system.

Treatment:

Other: Vanadis NIPT system