[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640648":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":42,"locations":10,"responsibleParty":52,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":10,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":76,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":10},{"fullName":5,"class":6},"Shanghai Jiao Tong University School of Medicine","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Colorectal cancer patients",null,"Patients with pathologically confirmed colorectal cancer. Colorectal tumor and adjacent normal tissue specimens will be analyzed for SLC15A3 expression, or serum specimen will be analyzed for histidine-related metabolites, or whole blood samples will be analyzed for peripheral blood immune cell functions.",[13,14],"Other: Immunohistochemistry or immunofluorescence","Other: Flow cytometry",{"label":16,"type":10,"description":17,"interventionNames":18},"ICB responders","Patients with colorectal cancer who previously received PD-1 immune checkpoint blockade and achieved a clinical response. Tumor tissue will be analyzed for SLC15A3 expression, and serum specimen will be analyzed for histidine-related metabolites.",[13,19],"Other: Serum metabolomic analysis or ELISA",{"label":21,"type":10,"description":22,"interventionNames":23},"ICB non-responders","Patients with colorectal cancer who previously received PD-1 immune checkpoint blockade and did not achieve a clinical response. Tumor tissue will be analyzed for SLC15A3 expression, and serum specimen will be analyzed for histidine-related metabolites.",[13,19],[25,29,33],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Immunohistochemistry or immunofluorescence","Formalin-fixed paraffin-embedded (FFPE) colorectal tumor and adjacent normal tissue specimens will be analyzed for SLC15A3 expression by immunohistochemistry and\u002For immunofluorescence.",[9,21,16],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"Serum metabolomic analysis or ELISA","Serum specimens from patients with colorectal cancer will be analyzed for histidine and related metabolites and selected biomarkers by metabolomics and\u002For ELISA.",[21,16],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"Flow cytometry","Peripheral blood mononuclear cells (PBMCs) will be separated from whole blood samples and assessed for immune cell phenotype and functional markers by flow cytometry.",[9],[38],{"name":39,"affiliation":40,"role":41},"Jing-Yuan Fang, M.D.","Division of Gastroenterology and Hepatology, NHC Key Laboratory of Digestive Diseases, Renji Hospital, School of Medicine, Shanghai Jiao Tong University","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":10,"email":47},"Wan Du, M.D.","CONTACT","(86)13788972966","duwan2017@126.com",{"name":49,"role":45,"phone":50,"phoneExt":10,"email":51},"Youli Chen","(86)13656503169","chenylpetri@gmail.com",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Jing-yuan Fang, MD, Ph. D","Professor Dr. Jing-yuan Fang","100640648","histidine-and-immunotherapy-response-in-colorectal-cancer-100640648",false,"NCT07586293","Histidine and Immunotherapy Response in Colorectal Cancer","Mechanistic Study of Histidine-mediated Regulation of Antigen Presentation in Colorectal Cancer to Enhance Sensitivity to Immunotherapy","Inclusion Criteria:\n\n1. Participants aged ≥18 years and ≤100 years.\n2. Patients pathologically diagnosed with colorectal cancer based on colonoscopy or surgical specimens and biopsy examination; or patients who previously received PD-1 monoclonal antibody immunotherapy for colorectal cancer.\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years.\n2. Presence of poorly controlled metabolic diseases, including hypertension, diabetes mellitus, hyperlipidemia, hyperuricemia, or hyperthyroidism.\n3. Presence of other severe gastrointestinal diseases, including inflammatory bowel disease, ischemic bowel disease, familial adenomatous polyposis, liver cirrhosis, MUTYH-associated polyposis (MAP), Lynch syndrome (LS), or Peutz-Jeghers syndrome (PJS).\n4. History of other malignant tumors, or pathological diagnosis of colorectal inflammatory polyps, hyperplastic polyps, neuroendocrine tumors, neuroendocrine carcinoma, or mixed neuroendocrine-non-neuroendocrine neoplasms.\n5. History of neurological or psychiatric disorders, such as epilepsy or depression.\n6. Unqualified specimens, including hemolyzed serum samples or tissue samples that were not properly preserved in time.","ALL","18 Years",{"count":66,"type":67},150,"ESTIMATED","OBSERVATIONAL","This observational study aims to investigate the role of histidine and its transporter SLC15A3 in modulating the sensitivity of colorectal cancer to immunotherapy. By analyzing the expression of SLC15A3 in tumor\u002Fnormal colonic tissues from patients with colorectal cancer and assessing serum histidine metabolic levels, the study seeks to identify potential targets associated with therapeutic resistance and explore possible intervention strategies to improve immune checkpoint blockade treatment efficacy.",[71],"Colorectal Cancer",[73,74,75],"Colorectal cancer","Histidine","immune checkpoint blockade","NOT_YET_RECRUITING","2026-05-12",{"date":79,"type":80},"2026-05-14","ACTUAL",{"date":82,"type":67},"2026-05",{"date":84,"type":67},"2027-06",{"name":54,"class":6}]