Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2023-11-28
2026-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Sub-group S-P
20 professional athletes whose weekly sport practice is more than 8 hours of contact sport.
Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion
Saliva of participants will be sampled for analysis of biomarkers of interest (nucleic acids and proteins). The nucleic acids biomarkers will be quantified by reverse transcription followed by amplification (RT-PCR) and Next Generation Sequencing (NGS) techniques while enzymatic assay methods (ELISA) methods will be used to quantify protein biomarkers.
Sub-group S-L
20 amateur athletes, having moderate physical activity whose weekly sport practice is between 4 and 8 hours of contact sport.
Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion
Saliva of participants will be sampled for analysis of biomarkers of interest (nucleic acids and proteins). The nucleic acids biomarkers will be quantified by reverse transcription followed by amplification (RT-PCR) and Next Generation Sequencing (NGS) techniques while enzymatic assay methods (ELISA) methods will be used to quantify protein biomarkers.
Sub-group S-O
20 control subjects who are occasional sport practitioners, having a low intensity physical activity with weekly practicing time is below 4h, excluding contacted sports.
Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion
Saliva of participants will be sampled for analysis of biomarkers of interest (nucleic acids and proteins). The nucleic acids biomarkers will be quantified by reverse transcription followed by amplification (RT-PCR) and Next Generation Sequencing (NGS) techniques while enzymatic assay methods (ELISA) methods will be used to quantify protein biomarkers.
Interventions
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Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion
Saliva of participants will be sampled for analysis of biomarkers of interest (nucleic acids and proteins). The nucleic acids biomarkers will be quantified by reverse transcription followed by amplification (RT-PCR) and Next Generation Sequencing (NGS) techniques while enzymatic assay methods (ELISA) methods will be used to quantify protein biomarkers.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
18 Years
40 Years
MALE
Yes
Sponsors
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Sys2Diag
OTHER_GOV
Responsible Party
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Thi Nhu Ngoc VAN
Senior Researcher/Project Manager
Central Contacts
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References
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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.
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.
Other Identifiers
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2023-A00188-37
Identifier Type: -
Identifier Source: org_study_id