Prenatal Analysis of Cell-free Circulating Fetal DNA

NCT06864806 | Recruiting

• 1 other identifier: CHUBX 2024/80
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In criminal cases involving sexual assault, victims may later discover they are pregnant, creating profound uncertainty about the paternity of the fetus. These distressing situations compound the trauma already experienced by the victims. To address this, the Medico-Legal Hematology Laboratory (LHML) in Bordeaux aims to validate a method based on Massively Parallel Sequencing (MPS) and a specific isolation protocol for analyzing cell-free circulating fetal DNA (ccfDNA) in maternal blood samples. This identification process will confirm or exclude paternal genetic relationships between the fetus and potential fathers between 6 and 22 weeks of amenorrhea. These analyses will only be conducted under judicial requisition, in accordance with the French Code of Criminal Procedure

Conditions

Pregnancy Related

Keywords

Non-invasive; Prenatal analysis; ccfDNA; MPS; Paternal filiation; Sexual assault

Outcome Measures

Primary Outcomes (1)

• Quality of Genetic profile

  The quality of the genetic profile obtained with the ForenSeq MainstAY kit will be estimated as a percentage of validated markers (loci) among the 27 autosomal markers analyzed by the kit

  Baseline

Secondary Outcomes (2)

• Free circulating fetal DNA

  Baseline

• Maternal blood

  Baseline

Study Arms (1)

Genetic profile

EXPERIMENTAL

Filiation analysis between the fetus and his father

Other: Genetic profile

Interventions

Genetic profile OTHER

Filiation analysis between the fetus and his father

Genetic profile

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Bordeaux, France

RECRUITING

MeSH Terms

Interventions

Genetic Profile

Intervention Hierarchy (Ancestors)

Genetic Background; Genetic Phenomena

Central Study Contacts

Loic Sentilhes, MD, PhD

CONTACT

+33 556 79 55 79; loic.sentilhes@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

FR (1)