[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633561":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":20,"studyPopulation":21,"armGroups":22,"interventions":11,"overallOfficials":24,"centralContacts":28,"locations":11,"responsibleParty":34,"collaborators":11,"id":37,"slug":11,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":40,"acronym":11,"eligibilityCriteria":41,"healthyVolunteers":38,"sex":42,"minAge":43,"maxAge":11,"enrollmentInfo":44,"targetDuration":11,"studyType":47,"phases":11,"briefSummary":48,"conditions":49,"keywords":11,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":11},{"fullName":5,"class":6},"Tongji Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Radiation-induced intestinal injury",null,"1 year",[14],{"measure":15,"description":11,"timeFrame":16},"overall survival","5 years",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":18,"timePerspective":19,"maskingInfo":11},"COHORT","PROSPECTIVE","1. Enroll eligible patients and obtain written informed consent.\n2. Collect clinical data.\n3. Sample collection and biomarker assessment: Peripheral blood, urine, and stool samples will be collected from patients before the initiation of radiotherapy and after the start of radiotherapy, followed by multi-omics analyses.\n4. Patient follow-up: Patients will be followed during radiotherapy, within 1 month after completion of treatment, and every 3 months thereafter; after 1 year, follow-up will be conducted every 6 months. Patients' symptoms, laboratory tests, and examination results will be recorded. Radiation-induced intestinal injury and its grading will be assessed according to the Radiation Therapy Oncology Group (RTOG) criteria. In addition, treatments and outcomes after the occurrence of radiation-induced intestinal injury will be documented.\n\n   The primary endpoint is radiation-induced intestinal injury, and the secondary endpoint is overall survival.\n5. Data integration: Clinical data, previous research findings, and biomarkers measured from patient samples will be integrated to identify biomarkers of radiation-induced intestinal injury and to develop a predictive model using bioinformatics approaches.","Patients with malignant tumors undergoing abdominal radiotherapy that may involve the intestine",[23],{"label":21,"type":11,"description":11,"interventionNames":11},[25],{"name":26,"affiliation":5,"role":27},"Bo Liu","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Lingyan Xiao","CONTACT","027-15971474885","lingyanxiao@hust.edu.cn",{"type":27,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"bo liu","Associate Professor","100633561",false,"NCT07528287","Study on Biomarkers of Radiation-Induced Intestinal Injury","Inclusion Criteria:\n\n1. Abdominal radiotherapy dose ≥45 Gy;\n2. Age ≥18 years;\n3. Karnofsky Performance Status (KPS) \\>60;\n4. Expected survival \\>6 months.\n\nExclusion Criteria:\n\n1. Prior history of abdominal radiotherapy;\n2. Active intestinal infection;\n3. Intestinal inflammatory diseases due to other causes;\n4. Inability to provide biological samples.","ALL","18 Years",{"count":45,"type":46},220,"ESTIMATED","OBSERVATIONAL","1. To identify biomarkers of radiation-induced intestinal injury;\n2. To develop a predictive model for radiation-induced intestinal injury.",[50],"Radiation-induced Intestinal Injury","NOT_YET_RECRUITING","2026-04-07",{"date":54,"type":55},"2026-04-14","ACTUAL",{"date":57,"type":46},"2026-04",{"date":59,"type":46},"2031-12",{"name":5,"class":6}]