[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527560":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":38,"studyPopulation":39,"armGroups":40,"interventions":54,"overallOfficials":60,"centralContacts":64,"locations":70,"responsibleParty":94,"collaborators":97,"id":101,"slug":34,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":34,"studyType":115,"phases":34,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":73,"whyStopped":34,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Sys2Diag","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":34},[9,13],{"measure":10,"description":11,"timeFrame":12},"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\u002For matches).\n\nExpression level of acid nucleic biomarkers are measured in copies\u002FµL, number of read and fold change.","3 years",{"measure":10,"description":14,"timeFrame":12},"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\u002For matches). Expression level of protein biomarkers including UCL-L1, GFAP, NSE are measured in pg\u002FmL.",[16,19,22,25,28,31],{"measure":17,"description":18,"timeFrame":12},"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.\n\nExpression level of acid nucleic biomarkers are measured in copies\u002FµL and fold change.",{"measure":20,"description":21,"timeFrame":12},"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.\n\nExpression level of protein biomarkers including UCL-L1, GFAP, NSE are measured in pg\u002FmL.",{"measure":23,"description":24,"timeFrame":12},"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.\n\nExpression level of acid nucleic biomarkers are measured in copies\u002FµL, number of read and fold change.",{"measure":26,"description":27,"timeFrame":12},"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.",{"measure":29,"description":30,"timeFrame":12},"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.\n\nExpression level of acid nucleic biomarkers are measured in copies\u002FµL, number of read and fold change.",{"measure":32,"description":33,"timeFrame":12},"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.\n\nExpression level of protein biomarkers including UCL-L1, GFAP, NSE are measured in pg\u002FmL.",null,{"allocation":34,"interventionModel":34,"interventionModelDescription":34,"primaryPurpose":34,"observationalModel":36,"timePerspective":37,"maskingInfo":34},"COHORT","PROSPECTIVE","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.\n\nRecently, 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.\n\nTo 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\u002For matches.","A total of 80 subjects will be recruited:\n\n* 30 professional sport subject, playing in the professional team of the Montpellier HandBall club (MHB) or the Montpellier Hérault Rugby (MHR) - BRAS S-P.\n* 30 leisure sport subjects with moderate physical activity playing in the leisure team of clubs associated with the Montpellier Handball (MHB) or the Rugby Club Méditerranée (RCM) or even to the clubs associated with the Montpellier Handball (MHB) or the Rugby Club Méditerranée (RCM) - BRAS S-L.\n* 20 occasional sport subjects with low intensity physical activity and whose weekly sports practice is less than 4 hours, excluding contact sports, recruited at Sys2diag, delegation 13 of CNRS or in sports clubs linked to the study - BRAS S-O.",[41,46,50],{"label":42,"type":34,"description":43,"interventionNames":44},"Sub-group S-P","30 professional athletes whose weekly sport practice is more than 8 hours of contact sport.",[45],"Diagnostic Test: Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion",{"label":47,"type":34,"description":48,"interventionNames":49},"Sub-group S-L","30 amateur athletes, having moderate physical activity whose weekly sport practice is between 4 and 8 hours of contact sport.",[45],{"label":51,"type":34,"description":52,"interventionNames":53},"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.",[45],[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":34},"DIAGNOSTIC_TEST","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.",[47,51,42],[61],{"name":62,"affiliation":5,"role":63},"Thi Nhu Ngoc VAN, Phd","PRINCIPAL_INVESTIGATOR",[65],{"name":66,"role":67,"phone":68,"phoneExt":34,"email":69},"Wendpouiré A OUEDRAOGO, Msc","CONTACT","+33 (0) 467 047 481","alimata.ouedraogo@sys2diag.cnrs.fr",[71],{"facility":72,"status":73,"city":74,"state":34,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Sys2Diag - Umr9005 Cnrs\u002FAlcen","RECRUITING","Montpellier","34184","France","FR",{"type":79,"coordinates":80},"Point",[81,82],3.87635,43.61093,{"lat":82,"lon":81},[85,89,90,91],{"name":86,"role":67,"phone":87,"phoneExt":34,"email":88},"Franck MOLINA, Phd","+33 (0) 467 047 460","s2d.cpp@sys2diag.cnrs.fr",{"name":66,"role":67,"phone":68,"phoneExt":34,"email":88},{"name":62,"role":63,"phone":34,"phoneExt":34,"email":34},{"name":92,"role":93,"phone":34,"phoneExt":34,"email":34},"Malik KAHLI, Phd","SUB_INVESTIGATOR",{"type":63,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Thi Nhu Ngoc VAN","Senior Researcher\u002FProject Manager",[98],{"name":99,"class":100},"Centre National de la Recherche Scientifique, France","OTHER","100527560",false,"NCT06149351","Salivary Biomarkers for Concussion","Determination of the Physiological Profile and Evaluation of the Effect of Intense Physical Exertion Among Professional Athletes","SportCo","Inclusion Criteria:\n\n* Male participants aged between 18 and 50 years old.\n* Participants willing to comply with the study procedures.\n* Participants capable of understanding the purpose, nature, and methodology of the study.\n* Participants affiliated to a French social security system or beneficiaries of such a system.\n* Participants who have signed the non-opposition form to participate in the research.\n\nNon-inclusion Criteria:\n\n* Participant not affiliated to a French social security system or not a beneficiary of such a system.\n* Participants deprived of liberty, protected adults, vulnerable individuals, or minors.\n* 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).\n* Refusal to sign the non-opposition form to participate in the research.\n\nNon-inclusion specific criteria\n\n* Subject who has had a recent stroke or epilepsy event (within the past two months).\n* Subject suffering from neurological diseases.",true,"MALE","18 Years","50 Years",{"count":113,"type":114},80,"ESTIMATED","OBSERVATIONAL","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.\n\nRecently, 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.",[118],"Sport Related Concussion",[120],"Concussion, Biomarkers, Sport","2026-03-12",{"date":123,"type":124},"2026-03-16","ACTUAL",{"date":126,"type":124},"2023-12-12",{"date":128,"type":114},"2027-12-12",{"name":5,"class":6},1]