Validate Non-invasive Prenatal Tests for the Detection of Chromosomal Abnormalities

NCT05618431 | Unknown

• 1 other identifier: 2022-A00290-43
• Study Type: interventional
• Target: 1,790
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted on pregnant patients for whom there is a suspicion of a chromosomal abnormality of the fetus. These are patients eligible for non-invasive prenatal screening as part of their usual pregnancy surveillance. This research aims to develop and validate a new method for non-invasive prenatal testing. This prospective collection study will allow the collection of biological samples necessary for the development, testing and validation of these new tests

Conditions

Validation of New Test NIPT

Outcome Measures

Primary Outcomes (1)

• Evaluation of the non-inferiority of a new non-invasive test for the detection of chromosomal abnormalities by analyzing the fetal DNA present in maternal blood by a new generation digital PCR

  As part of this study, comparative analyses will be carried out: For qualitative variables: Pearson's Chi ² test will be used unless the estimated theoretical number in a cell is less than five, in which case the Yates continuity correction or the exact Fisher test will be applied. For quantitative variables: the t-test or an analysis of Student's variance will be performed. Otherwise, post-hoc analyses will be performed using the Student-Neuman-Keuls test. If the data is not distributed normally, nonparametric tests will be used.

  18 months

Study Arms (1)

pregnant women

OTHER

Pregnant woman 18 and 50 years oldbetween 10 and 40 weeks of pregnancy

Other: NIPT

Interventions

NIPT OTHER

This research aims to develop and validate a new method for non-invasive prenatal testing

pregnant women

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Pregnant woman between 10 and 40 weeks of pregnancy 2. Gestational age at time of collection of the known sample 3. Maternal age 18-50 years 4. Sex of the fetus or newborn known (confirmed by doctor or karyotype) 5. Number of known fetuses 6.a) for affected samples: result of the karyotype available 6.b) for unaffected samples: preferably, result of the available karyotype; A secondarily negative NIPT result associated with a doctor's confirmation of the delivery of a healthy baby.
• \. 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.
• Confirmed mosaic sample
• Confirmed maternal mosaicism
• Recent maternal blood transfusion known
• Patient who received an organ transplant
• Patient who underwent surgery
• Patient on immunotherapy or stem cell therapy and/or other maternal malignancy
• Patient already included in the study during pregnancy
• Patient under guardianship or curatorship or safeguard of justice

Sponsors & Collaborators

• CerbaXpert: lead

Study Sites (1)

APHP

Paris, France

RECRUITING

MeSH Terms

Interventions

dichlorobis(azomycin)platinum II

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Demonstrating non-inferiority means ensuring that the product tested does not have an efficacy that would be too inferior to the reference product.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 16, 2022
• Study Start: February 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-12

Locations

FR (1)