Validate Non-invasive Prenatal Tests for the Detection of Chromosomal Abnormalities
NCT ID: NCT05618431
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1790 participants
INTERVENTIONAL
2023-02-01
2024-06-01
Brief Summary
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This prospective collection study will allow the collection of biological samples necessary for the development, testing and validation of these new tests
Detailed Description
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The secondary objective of this research: is to validate the reliability of the test on both populations (affected and unaffected) and its ability to detect the following anomalies: Triple X and 22q.11.2 Micro-deletion.
Type and methodology of research :
Although the only act of the research being the sampling of a maximum of 3 additional blood tubes for a maximum volume of 30 mL during a blood test as part of the care, this study is qualified as research involving the human person at risk and minimal constraints.
Provisional research calendar :
The inclusion period for subjects is 18 months, from the date of inclusion of the first patient.
The duration of the subjects' participation in this research protocol is related to the time of inclusion and the procedure of blood collection by venipuncture.
The end of participation of patients included in the study is effective as soon as the collection of the sample is completed.
Primary endpoint:
Evaluation of the non-inferiority of a new non-invasive test for the detection of chromosomal abnormalities and to determine the accuracy of fetal sex classification by the new NIPT method combined with next-generation digital PCR from acellular fetal DNA found in maternal plasma.
Secondary endpoint:
Evaluation of test performance in both populations (affected and unaffected) Evaluation of the performance of the test to detect the following anomalies: Triple X and 22q.11.2 Micro-deletion.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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pregnant women
Pregnant woman 18 and 50 years oldbetween 10 and 40 weeks of pregnancy
NIPT
This research aims to develop and validate a new method for non-invasive prenatal testing
Interventions
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NIPT
This research aims to develop and validate a new method for non-invasive prenatal testing
Eligibility Criteria
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Inclusion Criteria
7\. Have a diagnostic result (such as amniocentesis or CVS) available if NIPT is positive 8. Patients Affiliated to a social security scheme or entitled to.
1. Confirmed mosaic sample
2. Confirmed maternal mosaicism
3. Recent maternal blood transfusion known
4. Patient who received an organ transplant
5. Patient who underwent surgery
6. Patient on immunotherapy or stem cell therapy and/or other maternal malignancy
7. Patient already included in the study during pregnancy
8. Patient under guardianship or curatorship or safeguard of justice
18 Years
50 Years
FEMALE
No
Sponsors
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CerbaXpert
OTHER
Responsible Party
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Locations
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APHP
Paris, , France
Countries
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Facility Contacts
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BENACCHI Alexandra
Role: primary
Other Identifiers
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2022-A00290-43
Identifier Type: -
Identifier Source: org_study_id