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NCT05618431
Validate Non-invasive Prenatal Tests for the Detection of Chromosomal Abnormalities
Conditions: Validation of New Test NIPT
Sex: Female
Ages: 18 Years – 50 Years
Phase: NA
Enrollment: 1790
Sponsor: CerbaXpert
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
Eligibility Criteria
Inclusion criteria1. 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.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.Non-inclusion criteriaConfirmed mosaic sampleConfirmed maternal mosaicismRecent maternal blood transfusion knownPatient who received an organ transplantPatient who underwent surgeryPatient on immunotherapy or stem cell therapy and/or other maternal malignancyPatient already included in the study during pregnancyPatient under guardianship or curatorship or safeguard of justice
Source: ClinicalTrials.gov (NCT05618431). StuddyBuddy aggregates publicly available trial information.