Saliva biomarkers to help detect sport-related concussion
Determination of the Physiological Profile and Evaluation of the Effect of Intense Physical Exertion Among Professional Athletes
This project will test whether saliva biomarkers can help detect sport-related concussion in men aged 18 to 50.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Sponsor | Sys2Diag Government |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06149351 on ClinicalTrials.gov |
What this trial studies
This is an observational study collecting saliva samples to measure protein and nucleic acid biomarkers linked to sport-related concussion. Researchers will establish normal (reference) biomarker profiles in healthy athletes and document how those levels change after concussion. Samples will be analyzed using bio-fluid assays at the Montpellier site in collaboration with CNRS to support development of a diagnostic test. Participants are adult males who meet inclusion criteria and can provide informed non-opposition consent.
Who should consider this trial
Good fit: Ideal candidates are male athletes aged 18–50 who are affiliated with the French social security system, able to consent, and willing to provide saliva samples at the Montpellier site.
Not a fit: People who are female, younger than 18 or older than 50, not affiliated with the French social security system, legally protected or deprived of liberty, or with disqualifying infectious conditions are not eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, the work could enable a simple, noninvasive saliva test to help diagnose sport-related concussion more reliably and quickly.
How similar studies have performed: Previous research has identified candidate salivary biomarkers in athletes, but reference ranges and robust validation for diagnostic use remain incomplete.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male participants aged between 18 and 50 years old. * Participants willing to comply with the study procedures. * Participants capable of understanding the purpose, nature, and methodology of the study. * Participants affiliated to a French social security system or beneficiaries of such a system. * Participants who have signed the non-opposition form to participate in the research. Non-inclusion Criteria: * Participant not affiliated to a French social security system or not a beneficiary of such a system. * Participants deprived of liberty, protected adults, vulnerable individuals, or minors. * Participants with a proven or suspected chronic infectious disease that may introduce a risk of contamination during sample handling (laboratories not equipped to handle this type of sample). * Refusal to sign the non-opposition form to participate in the research. Non-inclusion specific criteria * Subject who has had a recent stroke or epilepsy event (within the past two months). * Subject suffering from neurological diseases.
Where this trial is running
Montpellier
- Sys2Diag - Umr9005 Cnrs/Alcen — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Thi Nhu Ngoc VAN, Phd — Sys2Diag
- Study coordinator: Wendpouiré A OUEDRAOGO, Msc
- Email: alimata.ouedraogo@sys2diag.cnrs.fr
- Phone: +33 (0) 467 047 481
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.