Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-27 @ 11:01 PM
Study NCT ID:
NCT06888635
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-21
First Post:
2025-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting the Metabolic Biomarkers Associated With Injury in Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-16', 'studyFirstSubmitDate': '2025-03-02', 'studyFirstSubmitQcDate': '2025-03-16', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with athletes with acute injuries', 'timeFrame': '1year', 'description': 'Acute injuries are defined as the injuries of body tissues in a short period of time due to sudden external force or improper operation during sports.This injury usually has sudden and distinct traumatic features'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sports medicine,', 'injury', 'biomarker', 'metabolite'], 'conditions': ['Sports Medicine']}, 'descriptionModule': {'briefSummary': "For elite athletes, sports injuries significantly impede the further enhancement of their competitive performance. Consequently, the significance of preventing, detecting, and addressing potential injury issues has become increasingly critical. Currently, the comprehensive evaluation of athletes' physical function and condition primarily depends on a range of physiological, biochemical, and immunological indicators. However, these methods have progressively exposed their limitations. As an advanced bioinformatics technology, omics research demonstrates unique advantages. By leveraging multi-omics research and analysis, it is possible to more accurately observe the physiological and biochemical changes that athletes undergo during training and competition, as well as their regulatory mechanisms. This approach can provide practical data, identify biomarkers that can warn of potential injuries, and offer precise guidance for training monitoring and injury prevention. It also provides a foundation for developing diverse, precise, and personalized sports programs and rehabilitation plans.", 'detailedDescription': 'Investigators will collect fasting venous blood. White blood cell count, red blood cell count, erythrocyte specific volume, hemoglobin, C-reactive protein, procalcitonin, erythrocyte sediment rate, lactic acid,creatine kinase, liver function indicators, blood urea, blood creatinine, blood uric acid, blood testosterone, blood cortisol, immunoglobulin (IgG, IgA, IgM) and ferritin levels were measured. The levels of IL-2, IL-6, IL-1β and TNF-α were determined by ELISA. Blood samples were purified and analyzed by proteomics, metabolomics and lipidomics methods. Urine and stool samples were collected and analyzed by multi-omics method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Athletes in sports, due to sudden external force or improper operation, resulting in body tissue damage in a short period of time. This injury usually has sudden and distinct traumatic features, and common types include:\n\n1. Sprain: Joint due to excessive torsion or stretching, resulting in ligament damage.\n2. Strain: An injury to a muscle or tendon caused by excessive stretching or contraction.\n3. Contusion: A direct impact on the body part causes damage to the subcutaneous tissue, which may be accompanied by bruising.\n4. Fracture: The bone is broken due to external force.\n5. Dislocation: The joint is removed from its normal position due to external forces.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age： Athletes 12-30 years old\n2. Acute injury during exercise: such as muscle, sprain, contusion, torn ligament, dislocation, fracture.\n\nExclusion Criteria:\n\n1. Athletes with serious cardio-cerebrovascular disease and abnormal liver and kidney function\n2. Recent use of drugs or supplements that affect metabolism.\n3. Pregnancy, lactation or special conditions that may affect metabolism.'}, 'identificationModule': {'nctId': 'NCT06888635', 'briefTitle': 'Predicting the Metabolic Biomarkers Associated With Injury in Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Predicting the Metabolic Biomarkers Associated With Injury in Athletes', 'orgStudyIdInfo': {'id': 'XH-25-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute Injury athletes', 'description': 'Athletes in sports, due to sudden external force or improper operation, resulting in body tissue damage in a short period of time. This injury usually has sudden and distinct traumatic features, and common types include:\n\n1. Sprain: Joint due to excessive torsion or stretching, resulting in ligament damage.\n2. Strain: An injury to a muscle or tendon caused by excessive stretching or contraction.\n3. Contusion: A direct impact on the body part causes damage to the subcutaneous tissue, which may be accompanied by bruising.\n4. Fracture: The bone is broken due to external force.\n5. Dislocation: The joint is removed from its normal position due to external forces.'}, {'label': 'Healthy athletes', 'description': 'athletes with no acute injury in the last 3 months'}, {'label': 'Healthy', 'description': 'Healthy non-athlete population'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Yue Zhang, Doctor', 'role': 'CONTACT', 'email': 'pyramidzhang@163.com', 'phone': '+862125077373'}, {'name': 'Yue Zhang, Doctor', 'role': 'CONTACT', 'email': 'pyramidzhang@163.com', 'phone': '02125077373'}, {'name': 'Yue Zhang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Respiratory, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yue Zhang, Doctor', 'role': 'CONTACT', 'email': 'pyramidzhang@163.com', 'phone': '+862125077373'}], 'overallOfficials': [{'name': 'Yue Zhang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Respiratory, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}