NCT04737070

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

February 3, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 25, 2021

Last Update Submit

January 31, 2021

Conditions

Trisomy 21

Outcome Measures

Primary Outcomes (1)

  • number of genetics anomalies

    through study completion, an average of 9 months

Interventions

Prenatal test for Trisomy 21 screeningBIOLOGICAL

prenatal routine test for Trisomy 21 screening (blood test + nuchal translucency test)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

High risk population for prenatal screening of Trisomy 21

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor (MD)

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 3, 2021

Study Start

February 1, 2021

Primary Completion

April 1, 2021

Study Completion

July 1, 2021

Last Updated

February 3, 2021

Record last verified: 2021-01