CHU de Montpellier
Montpellier, France, 34295
Location status: Recruiting
Location contact
Vincent GATINOIS, Dr
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06523543
Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities.
Interested in participating?
Request Info18 year and older
Female
Observational
Montpellier, France, 34295
Location status: Recruiting
Vincent GATINOIS, Dr
PRINCIPAL_INVESTIGATOR
During pregnancy, biological screening for genetic diseases of the fetus cannot be implemented before the 11th week of amenorrhea whatever the technique used. This delay is long and distressing, particularly for people at high risk of transmission of genetic diseases. The presence of extravillous trophoblast cells to the cervix of the pregnant woman from the 7th week, accessible by a cervicovaginal smear non-invasive, represents new biological material representative of the fetal genome. This project aimed at evaluating the performance of a method for analyzing these trophoblast cells extra-villous at the start of pregnancy. The investigators want to evaluate performance analytical aspects of this method, that is to say, verifying that the genetic information resulting from these cells correspond to those of the fetus.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusions Criteria:
Extraction of cervico-vaginal sampling
Ultrasound examination (determination of chromosomal sex)
Ultrasound examination (determination of chromosomal sex) if this has not be done during the Visit 2 or if a new determination correcting the previous one is provided.
Time frame: Visit 2 (Week 20-24)
Collect fetal phenotypic data obtained during the second or the 3rd trimester via ultrasound echography
Time frame: Visit 2 (Week 20-24)
Time frame: Visit 2 (Week 20-24)
Evaluate the ability of the method to provide a rapid result and evaluate the impact of information about pregnant women
Contact information is provided by the study sponsor or research team.
University Hospital, Montpellier
Other
Acronym: CellF-Cervix
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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