Clinical trial NCT06149351: Salivary Biomarkers for Concussion
Official title: Salivary Biomarkers for Concussion : Determination of the Physiological Profile and Evaluation of the Effect of Intense Physical Exertion Among Professional Athletes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sport Related Concussion
Lead sponsor: Sys2Diag
Sponsor class: OTHER_GOV
First posted: 2023-11-29
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Recently, several salivary biomarkers (proteins and nucleic acids) of sport related concussion have been identified in professional athletes. However, their reference values have not been determined with sufficient robustness to enable their employment in concussion diagnostic tests. Toward a proper interpretation of the signal for a reliable diagnostic test, we aim to evaluate the physiological variations as well as the effect of different intensive trainings on the profile of these salivary biomarkers in professional athletes. Data generated form such analysis will help establish a baseline profile for these biomarkers whose change in intensity associated with concussion could be diagnosed in the future.


Eligibility criteria: Inclusion Criteria:

* Male participants aged between 18 and 40 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.

Primary outcomes:
measure: Evaluate the baseline level of salivary molecular biomarkers
timeFrame: 2 years
Secondary outcomes:
measure: Differential analysis of expression signatures of salivary sncRNAs of the three groups
timeFrame: 2 years
measure: Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups
timeFrame: 2 years
measure: Differential analysis of expression signatures of salivary sncRNAs of the three groups throughout different sport situations
timeFrame: 2 years
measure: Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups throughout different sport situations
timeFrame: 2 years
measure: Differential analysis of expression signatures of salivary sncRNAs of the three groups throughout the sports season
timeFrame: 2 years
measure: Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups throughout the sports season
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
citation: Di Pietro V, Ragusa M, Davies D, Su Z, Hazeldine J, Lazzarino G, Hill LJ, Crombie N, Foster M, Purrello M, Logan A, Belli A. MicroRNAs as Novel Biomarkers for the Diagnosis and Prognosis of Mild and Severe Traumatic Brain Injury. J Neurotrauma. 2017 Jun 1;34(11):1948-1956. doi: 10.1089/neu.2016.4857. Epub 2017 Apr 10.
citation: Di Pietro V, O'Halloran P, Watson CN, Begum G, Acharjee A, Yakoub KM, Bentley C, Davies DJ, Iliceto P, Candilera G, Menon DK, Cross MJ, Stokes KA, Kemp SP, Belli A. Unique diagnostic signatures of concussion in the saliva of male athletes: the Study of Concussion in Rugby Union through MicroRNAs (SCRUM). Br J Sports Med. 2021 Dec;55(24):1395-1404. doi: 10.1136/bjsports-2020-103274. Epub 2021 Mar 23.