Ultra-early Identification of Fetal Chromosomal Characteristics From Extravillous-trophoblast Cells

Recruiting

• Conditions: Pregnant Women
• Interventions: Procedure: Inclusion (Visit 1 - Week 7-16); Diagnostic Test: Second semester of pregnancy (Visit 2 - Week 20-24); Diagnostic Test: Third semester of pregnancy (Visit 3- Week 34)

• Registration Number: NCT06523543
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-26
• Study Start: 2024-11-19
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11
• Primary Completion: 2027-08-30
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• Pregnant woman
• Singleton pregnancy
• Pregnancy between 7 and 16 weeks of amenorrhea (WA)
• Woman ≥ 18 years
• Woman who has signed an informed consent
• Woman affiliated to social security or equivalent scheme

Exclusions Criteria:

• Person under guardianship or curatorship
• Person placed under legal protection
• Person unable to provide the participant with informed consent.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women	Inclusion (Visit 1 - Week 7-16)	Women who are pregnant between 7 and 16 weeks of amenorrhea (WA)
Pregnant women	Second semester of pregnancy (Visit 2 - Week 20-24)	Women who are pregnant between 7 and 16 weeks of amenorrhea (WA)
Pregnant women	Third semester of pregnancy (Visit 3- Week 34)	Women who are pregnant between 7 and 16 weeks of amenorrhea (WA)

Primary Outcome Measures

Name	Time	Method
Establish an ultra-early detection method	Visit 2 (Week 20-24)	Collect fetal phenotypic data obtained during the second or the 3rd trimester via ultrasound echography

Secondary Outcome Measures

Name	Time	Method
Expected benefit of ultra-early cytogenetic information	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
Evaluate the ability of the method to provide a result in the context of a progressive pregnancy	Visit 2 (Week 20-24)	* Time (minutes) elapsed between sampling and biological validation of the result; * Number of trophoblast cells identified; * Failure rate: number of samples for which biological signals were not successful to determine the fetal chromosomal sex

Trial Locations

Locations (1)

CHU de Montpellier; 🇫🇷 Montpellier, France