[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620439":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":30,"locations":36,"responsibleParty":122,"collaborators":125,"id":133,"slug":134,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":10,"eligibilityCriteria":139,"healthyVolunteers":135,"sex":140,"minAge":141,"maxAge":10,"enrollmentInfo":142,"targetDuration":10,"studyType":145,"phases":10,"briefSummary":146,"conditions":147,"keywords":151,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Shantou University Medical College","OTHER",[8,12,15,18,21,24,27],{"label":9,"type":10,"description":11,"interventionNames":10},"Neuro-Sensory irAE Cohort",null,"Participants who develop a grade ≥2 neurological, neurocognitive, psychiatric, ocular inflammatory, or peripheral nervous system immune-related adverse event.",{"label":13,"type":10,"description":14,"interventionNames":10},"Gastrointestinal and Hepatic irAE Cohort","Participants who develop grade ≥2 immune-mediated colitis, hepatitis, pancreatitis, or related gastrointestinal toxicities.",{"label":16,"type":10,"description":17,"interventionNames":10},"Rheumatology and Musculoskeletal irAE Cohort","Participants who develop grade ≥2 inflammatory arthritis, myositis, polymyalgia rheumatica-like syndromes, or related musculoskeletal toxicities.",{"label":19,"type":10,"description":20,"interventionNames":10},"Vascular and Renal irAE Cohort","Participants who develop grade ≥2 myocarditis, vasculitis, nephritis, or other vascular or renal immune-mediated toxicities.",{"label":22,"type":10,"description":23,"interventionNames":10},"Hematologic irAE Cohort","Participants who develop grade ≥2 immune-mediated cytopenias or other hematologic toxicities.",{"label":25,"type":10,"description":26,"interventionNames":10},"Multi-Organ irAE Cohort","Participants who develop two or more distinct grade ≥2 immune-related adverse events involving different organ systems.",{"label":28,"type":10,"description":29,"interventionNames":10},"Control Cohort","Participants who do not develop any grade ≥2 immune-related adverse events during the defined follow-up period.",[31],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"Yifei Ma, MD","CONTACT","8618883852716","myf61872169@163.com",[37,55,69,83,97,108],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"First Affiliated Hospital of Fujian Medical University","RECRUITING","Fuzhou","Fujian","430074","China","CN",{"type":46,"coordinates":47},"Point",[48,49],119.30611,26.06139,{"lat":49,"lon":48},[52,53],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},{"name":32,"role":54,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"facility":56,"status":39,"city":57,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Sun Yat-sen University Cancer Center","Guangzhou",{"type":46,"coordinates":59},[60,61],113.25,23.11667,{"lat":61,"lon":60},[64,68],{"name":65,"role":33,"phone":66,"phoneExt":10,"email":67},"Ao Zhang, MD","8618588811852","zhangao@sysucc.org.cn",{"name":65,"role":54,"phone":10,"phoneExt":10,"email":10},{"facility":70,"status":39,"city":71,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Hainan Hospital of Chinese PLA General Hospital","Sanya",{"type":46,"coordinates":73},[74,75],109.50947,18.25435,{"lat":75,"lon":74},[78,82],{"name":79,"role":33,"phone":80,"phoneExt":10,"email":81},"Jiacai Lin, MD","8615692537693","sovereignljc@126.com",{"name":79,"role":54,"phone":10,"phoneExt":10,"email":10},{"facility":84,"status":39,"city":85,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Affiliated Cancer Hospital of Shantou University Medical College","Shantou",{"type":46,"coordinates":87},[88,89],116.67876,23.35489,{"lat":89,"lon":88},[92,96],{"name":93,"role":33,"phone":94,"phoneExt":10,"email":95},"Xinjia Wang, MD","8613881841142","liuhaizhou@fjmu.edu.cn",{"name":93,"role":54,"phone":10,"phoneExt":10,"email":10},{"facility":98,"status":39,"city":85,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},"the First Affiliated Hospital of Shantou University Medical College",{"type":46,"coordinates":100},[88,89],{"lat":89,"lon":88},[103,107],{"name":104,"role":33,"phone":105,"phoneExt":10,"email":106},"Jun Lu, MD","8613531263375","jlu1@stu.edu.cn",{"name":104,"role":54,"phone":10,"phoneExt":10,"email":10},{"facility":109,"status":39,"city":110,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"The First Affiliated Hospital of Zhengzhou University","Zhengzhou",{"type":46,"coordinates":112},[113,114],113.64861,34.75778,{"lat":114,"lon":113},[117,121],{"name":118,"role":33,"phone":119,"phoneExt":10,"email":120},"Pengfei Zhu, MD","8613526664537","tesolik_trevolso@tom.com",{"name":118,"role":54,"phone":10,"phoneExt":10,"email":10},{"type":54,"investigatorFullName":123,"investigatorTitle":124,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Weidong Wang","Associate Professor, MD",[126,128,129,131],{"name":127,"class":6},"Fujian Medical University",{"name":109,"class":6},{"name":130,"class":6},"Sun Yat-sen University",{"name":132,"class":6},"Chinese PLA General Hospital","100620439","longitudinal-cohort-study-of-immune-related-adverse-events-in-solid-tumor-patients-treated-with-immune-checkpoint-inhibitors-100620439",false,"NCT07357636","Longitudinal Cohort Study of Immune-Related Adverse Events in Solid Tumor Patients Treated With Immune Checkpoint Inhibitors","Longitudinal Cohort Study of Immune-Related Adverse Events in Solid Tumor Patients Receiving Immune Checkpoint Inhibitors, With Deep Phenotyping and Multi-Omics Biomarker Discovery","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed solid malignancy\n* Planned initiation of a new immune checkpoint inhibitor regimen (monotherapy or combination) as standard of care or on an approved clinical trial\n* Ability to provide informed consent\n* Baseline study assessments and biospecimen collection completed prior to first ICI dose\n* Life expectancy of at least 6 months as determined by treating oncologist\n* Availability of archival tumor tissue or willingness to undergo biopsy if archival tissue is unavailable\n\nExclusion Criteria:\n\n* Uncontrolled medical, psychiatric, or social conditions that would interfere with study participation or data interpretation\n* Chronic systemic immunosuppression exceeding 10 mg\u002Fday prednisone equivalent within 14 days prior to enrollment (excluding inhaled, topical, or physiologic replacement doses)\n* Prior solid organ transplantation or allogeneic hematopoietic stem cell transplantation\n* Untreated, symptomatic, or progressing brain metastases (treated and stable brain metastases allowed if off systemic steroids for at least 7 days)\n* Inability or unwillingness to provide required baseline biospecimens","ALL","18 Years",{"count":143,"type":144},940,"ESTIMATED","OBSERVATIONAL","Immune checkpoint inhibitors (ICIs) have transformed the treatment of solid tumors but are associated with immune-related adverse events (irAEs) that can affect virtually any organ system. While many irAEs are well recognized, neurological, neurocognitive, and psychiatric toxicities remain diagnostically challenging, potentially severe, and poorly understood, with limited predictive biomarkers.\n\nThis prospective longitudinal observational cohort study enrolls adult patients with solid tumors initiating a new course of ICI therapy. Participants undergo standardized baseline clinical assessments and biospecimen collection prior to ICI initiation, followed by longitudinal follow-up and event-driven sampling. Patients are dynamically assigned to organ-specific irAE cohorts based on the first clinically significant irAE that dictates management. Patients without grade ≥2 irAEs during follow-up serve as a comparator control cohort.\n\nThe primary objective is to characterize longitudinal immune and inflammatory biomarker trajectories associated with the development of irAEs and to identify predictive and prognostic biomarkers, with particular emphasis on neurological, neurocognitive, and psychiatric toxicities. Integrated clinical, imaging, and multi-omics data will be used to elucidate mechanisms of toxicity and inform future risk stratification and personalized management strategies.",[148,149,150],"Solid Tumor","Immune-Related Adverse Events","Immunotherapy Toxicity",[152,153,154,155,156,157,158],"Immune checkpoint inhibitors","Immunotherapy","Biomarkers","Neurotoxicity","Neuroimmune adverse events","immune related adverse events","PD-1 blocker","2026-01-26",{"date":161,"type":162},"2026-01-28","ACTUAL",{"date":164,"type":162},"2019-01-10",{"date":166,"type":144},"2029-09-10",{"name":5,"class":6},6]