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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A00188-37 | Other Identifier | Comité de protection des personnes (French Ethics committee) |
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| Name | Class |
|---|---|
| Centre National de la Recherche Scientifique, France | OTHER |
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Concussion (CC) (also called mild head trauma), which accounts for 85% of all head injuries, is very common in professional and amateur athletes. CC is an injury to the brain resulting from the direct or indirect impact of external mechanical forces, momentarily disrupting its function on a cellular level. Unlike more serious head injury (moderate and severe), which can be diagnosed using neuroimaging techniques (CT, MRI, etc.), patients suffering from CC do not necessarily show visible signs of structural abnormalities. As a result, diagnosis of CC is offen difficult.
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.
Concussion (CC) (also called mild head trauma), which accounts for 85% of all head injuries, is very common in professional and amateur athletes. CC is an injury to the brain resulting from the direct or indirect impact of external mechanical forces, momentarily disrupting its function on a cellular level. Unlike more serious head injury (moderate and severe), which can be diagnosed using neuroimaging techniques (CT, MRI, etc.), patients suffering from CC do not necessarily show visible signs of structural abnormalities. As a result, diagnosis of CC is offen difficult. It is essentially based on subjective observational criteria and on the determination of the Glasgow Coma Scale (GCS) score, a score of 13 to 15 indicating potential CC. In approximately 15% of cases, symptoms such as momentary loss of consciousness (less than 30 minutes), amnesia lasting less than 24 hours, neurological deficit, or convulsions can be used to make a diagnosis. In the majority of cases, concussion goes undetected and no specific treatment or rehabilitation is put in place.
Recently, certain molecular biomarkers (BMs) of CC in elite athletes have been identified (Di Pietro et al. 2021; McCrea et al. 2020). However, the reference values of these BMs are not determined with sufficient robustness to enable the best use for concussion diagnostic tests.
To detect these biomarkers, it is first necessary to determine their physiological profiles as well as the changes in intensity associated with intense physical efforts during training session and/or matches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sub-group S-P | 30 professional athletes whose weekly sport practice is more than 8 hours of contact sport. |
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| Sub-group S-L | 30 amateur athletes, having moderate physical activity whose weekly sport practice is between 4 and 8 hours of contact sport. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the baseline level of salivary molecular biomarkers | Quantification of salivary small non coding RNA (sncRNA) biomarkers of all study subjects: before, during and after intense or moderate sports practice (training and/or matches). Expression level of acid nucleic biomarkers are measured in copies/µL, number of read and fold change. | 3 years |
| Evaluate the baseline level of salivary molecular biomarkers | Quantification of salivary biomarkers including ubiquitin c-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP) and neuron-specific enolase (NSE) proteins of all study subjects: before, during and after intense or moderate sports practice (training and/or matches). Expression level of protein biomarkers including UCL-L1, GFAP, NSE are measured in pg/mL. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Differential analysis of expression signatures of salivary sncRNAs of the three groups | Comparison of expression signatures of salivary sncRNAs among the professional athletes, amateur athletes, and occasional sport practitioners. Expression level of acid nucleic biomarkers are measured in copies/µL and fold change. | 3 years |
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Inclusion Criteria:
Non-inclusion Criteria:
Non-inclusion specific criteria
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A total of 80 subjects will be recruited:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wendpouiré A OUEDRAOGO, Msc | Contact | +33 (0) 467 047 481 | alimata.ouedraogo@sys2diag.cnrs.fr |
| Name | Affiliation | Role |
|---|---|---|
| Thi Nhu Ngoc VAN, Phd | Sys2Diag | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sys2Diag - Umr9005 Cnrs/Alcen | Recruiting | Montpellier | 34184 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28279125 | Background | 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. | |
| 33757972 |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Saliva
|
| Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups |
Comparison of expression signatures of salivary UCH-L1, GFAP, NSE proteins among the professional athletes, amateur athletes, and occasional sport practitioners. Expression level of protein biomarkers including UCL-L1, GFAP, NSE are measured in pg/mL. |
| 3 years |
| Differential analysis of expression signatures of salivary sncRNAs of the three groups throughout different sport situations | Comparison of expression signatures of salivary sncRNAs before, during and after different training sessions (bodybuilding, contact, etc) and matches. Expression level of acid nucleic biomarkers are measured in copies/µL, number of read and fold change. | 3 years |
| Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups throughout different sport situations | Comparison of expression level of salivary UCH-L1, GFAP, NSE proteins before, during and after different training sessions (bodybuilding, contact, etc) and matches. | 3 years |
| Differential analysis of expression signatures of salivary sncRNAs of the three groups throughout the sports season | Comparison of expression signatures of salivary sncRNAs at the beginning, in the middle and by the end of the sports season. Expression level of acid nucleic biomarkers are measured in copies/µL, number of read and fold change. | 3 years |
| Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups throughout the sports season | Comparison of expression level of salivary UCH-L1, GFAP, NSE proteins at the beginning, in the middle and by the end of the sports season. Expression level of protein biomarkers including UCL-L1, GFAP, NSE are measured in pg/mL. | 3 years |
| 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. |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |