Non‑invasive prenatal paternity testing using fetal DNA in maternal blood
Development of a Protocol for Non-Invasive Prenatal Analysis of Cell-Free Circulating Fetal DNA (ccfDNA) Using Massively Parallel Sequencing (MPS)
This project will test whether a blood draw from pregnant women between 6 and 22 weeks can use fetal DNA to confirm or exclude the baby's father when paternity is uncertain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT06864806 on ClinicalTrials.gov |
What this trial studies
The team will collect about 10 mL of maternal blood in special tubes between 6 and 22 weeks of amenorrhea to isolate cell‑free fetal DNA (ccfDNA) and analyze it with massively parallel sequencing (MPS). Buccal swabs from the parents and umbilical cord blood at birth will be used as reference samples to validate the fetal profile and filiation results. Samples will be processed using standardized extraction, quantification, and sequencing workflows to determine if the fetal genetic profile can be matched to a putative father. Analyses are performed under judicial requisition and follow French legal and ethical procedures.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 or older between 6 and 22 weeks of amenorrhea whose partner can provide a reference sample and who both give informed consent.
Not a fit: Patients unlikely to benefit include those with unknown paternity, maternal blood‑borne infections (HIV, syphilis, hepatitis B), inability of the father to provide a sample, insufficient French comprehension, or parents under legal protection.
Why it matters
Potential benefit: If successful, this method could offer a non‑invasive way to confirm or exclude paternity early in pregnancy, reducing uncertainty and aiding legal processes.
How similar studies have performed: Previous work on non‑invasive prenatal testing using ccfDNA and sequencing has shown promising accuracy for fetal genotyping and paternity, but methods for early pregnancy and forensic use remain under validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older. * For woman: pregnancy between 6 and 22 weeks * For both mother and father: non-opposition to participate and genetic signed informed consent Exclusion Criteria: * Unknown paternity. * Maternal blood-borne infections (HIV, syphilis, hepatitis B). * Inability of the father to provide a sample. * Insufficient comprehension of French by either parent. * Mother or father under legal protection
Where this trial is running
Bordeaux
- CHU Bordeaux — Bordeaux, France (Recruiting)
Study contacts
- Study coordinator: Loic Sentilhes, MD, PhD
- Email: loic.sentilhes@chu-bordeaux.fr
- Phone: +33 556 79 55 79
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.