Study of High Risk Non Invasive Prenatal Test Population

January 31, 2021 updated by: Matthieu DAP, Central Hospital, Nancy, France

The investigator want to study the population of high risk (over 1/50) of Trisomy 21.

According to french guidelines, these patients needs to have a invasive test (such as amniocentesis) but some patients prefer to have a Non Invasive Prenatal Test, with a potential lack of information.

Study Overview

Status

Unknown

Conditions

Trisomy 21

Intervention / Treatment

Biological: Prenatal test for Trisomy 21 screening

Study Type

Observational

Enrollment (Anticipated)

150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

High risk population for prenatal screening of Trisomy 21

Description

Inclusion Criteria:

Prenatal screening of Trisomy 21 > 1/50 (high risk population)

Exclusion Criteria:

No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of genetics anomalies Time Frame: through study completion, an average of 9 months	through study completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2021

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

January 31, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)