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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-20

Study Completion Date

2020-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

VAlidation of a Lower Cost aneUploidy scrEen

NCT03087357

Down Syndrome Trisomy 18 Trisomy 13

COMPLETED

Clinical Performance of NIPT in Multiple Gestation Pregnancies

NCT04488393

Trisomy 21 in Fetus

COMPLETED

Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies

NCT05004337

Vanishing Twin Trisomy 21 Trisomy 13 +1 more

COMPLETED

Development of Non-invasive Prenatal Screening Test for Microdeletions Based on Fetal DNA Isolated From Maternal Blood

NCT01852708

Trisomy 21 Trisomy 18 Trisomy 13 +2 more

COMPLETED

Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies

NCT03200041

Down Syndrome Patau Syndrome Edward's Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trisomy 21 Trisomy 18 Trisomy 13

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pregnant women

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

Vanadis NIPT system

Intervention Type OTHER

A novel cost effective not NGS (next-generation sequencing) test, based on imaging single DNA molecules for high precision NIPT (non-invasive prenatal testing)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vanadis NIPT system

A novel cost effective not NGS (next-generation sequencing) test, based on imaging single DNA molecules for high precision NIPT (non-invasive prenatal testing)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No