- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04737070
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
Intervention / Treatment
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
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)
February 3, 2021
Last Update Submitted That Met QC Criteria
January 31, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020PI310
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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PerkinElmer, Wallac OyAzienda Ospedaliera Città della Salute e della Scienza di TorinoUnknownTrisomy 21 | Trisomy 18 | Trisomy 13Italy
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Women and Infants Hospital of Rhode IslandNatera, Inc.CompletedTrisomy 21 | Trisomy 18 | Trisomy 13 | Monosomy XUnited States
Clinical Trials on Prenatal test for Trisomy 21 screening
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CHU de Quebec-Universite LavalCanadian Institutes of Health Research (CIHR); Laval University; Genome British... and other collaboratorsCompletedTrisomy 21 | Trisomy 18 | Trisomy 13Canada
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CHU de Quebec-Universite LavalUniversity of British Columbia; McGill University; Canadian Institutes of Health... and other collaboratorsActive, not recruitingAneuploidy | Prenatal DisorderCanada
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The Bird and Be Co IncRecruitingInfertility, Male | Spermatogenesis and Semen DisordersCanada
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National Taiwan University HospitalCompleted
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Sequenom, Inc.ObstetrixCompleted
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Hospices Civils de LyonCompletedHead and Neck Cancer | Digestive Cancer | Gynaecological CancerFrance
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Hacettepe UniversityCompletedSwallowing DisorderTurkey
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