Non‑invasive prenatal paternity testing using fetal DNA in maternal blood
Official title: Development of a Protocol for Non-Invasive Prenatal Analysis of Cell-Free Circulating Fetal DNA (ccfDNA) Using Massively Parallel Sequencing (MPS)
Run by University Hospital, Bordeaux · NCT06864806 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | September 2026 |
| Study ends | September 2026 |
| Registry record updated | September 16, 2025 |
| Trial ID | NCT06864806 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.