Prenatal Analysis of Cell-free Circulating Fetal DNA (NCT06864806) | Clinical Trial Compass
RecruitingNot Applicable
Prenatal Analysis of Cell-free Circulating Fetal DNA
France60 participantsStarted 2025-09-15
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.