Informations générales (source: ClinicalTrials.gov)
Prospective Biological Sample Collection Aiming to Validate Non-invasive Prenatal Tests by Analyzing Fetal DNA Present in Maternal Blood Using a Next-generation Digital PCR Technique (NIPT)
Interventional
N/A
CerbaXpert (Voir sur ClinicalTrials)
février 2023
juin 2024
29 juin 2024
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | KLEINFINGER Pascale | 14/02/2025 09:03:17 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHP - Paris - France | BENACCHI Alexandra | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion criteria
1. 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 criteria
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
1. 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 criteria
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