[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immune-related-adverse-events\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immune-related-adverse-events":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,36,57,85,116,149,180,208,229],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":26,"startDateStruct":29,"completionDateStruct":31,"leadSponsor":33,"locationsCount":4},"100633507","study-on-biomarkers-of-immune-related-adverse-events-100633507",false,"NCT07527585","Study on Biomarkers of Immune-Related Adverse Events","Inclusion Criteria:\n\n1. Age \\>18 years;\n2. Karnofsky Performance Status (KPS) \\>60;\n3. Expected to receive at least one cycle of immune checkpoint inhibitor therapy;\n4. Expected survival \\>6 months.\n\nExclusion Criteria:\n\n1. Prior treatment with immune checkpoint inhibitors;\n2. Active autoimmune diseases (including systemic lupus erythematosus, inflammatory bowel disease, rheumatoid arthritis, myasthenia gravis, scleroderma, etc.);\n3. Use of systemic immunosuppressive agents within 14 days prior to enrollment (prednisone \\>10 mg\u002Fday or equivalent);\n4. Inability to provide biological samples.","ALL","18 Years",{"count":18,"type":19},440,"ESTIMATED","OBSERVATIONAL","1. To identify biomarkers of immune-related adverse events;\n2. To develop a predictive model for immune-related adverse events.",[23],"Immune-Related Adverse Events","NOT_YET_RECRUITING","2026-04-07",{"date":27,"type":28},"2026-04-14","ACTUAL",{"date":30,"type":19},"2026-04",{"date":32,"type":19},"2032-12",{"name":34,"class":35},"Huazhong University of Science and Technology","OTHER",{"id":37,"slug":38,"hasResults":11,"nctId":39,"briefTitle":40,"officialTitle":40,"acronym":4,"eligibilityCriteria":41,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":42,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":44,"conditions":45,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":56},"100627800","immune-related-adverse-events-after-cancer-immunotherapy-and-safety-of-treatment-rechallenge-100627800","NCT07453342","Immune-Related Adverse Events After Cancer Immunotherapy and Safety of Treatment Rechallenge","Inclusion Criteria:\n\n* Adults (≥18 years old) with a diagnosis of malignant tumor.\n* Received treatment with immune checkpoint inhibitors (including anti-PD-1, anti-PD-L1, and\u002For anti-CTLA-4 agents).\n* Developed documented immune-related adverse events (irAEs) during ICI therapy, as determined by treating physicians.\n* Availability of clinical data for evaluation of irAE characteristics and outcomes.\n\nExclusion Criteria:\n\n* Patients receiving ICIs outside of the participating institution without accessible clinical records.\n* Insufficient clinical information to determine irAE diagnosis or outcomes.\n* Patients who decline use of their clinical data or biospecimens, when applicable.",{"count":43,"type":19},500,"This observational study aims to comprehensively characterize immune-related adverse events (irAEs) occurring during immune checkpoint inhibitor (ICI) therapy in cancer patients and to evaluate the safety and clinical outcomes of ICI rechallenge following irAE resolution.\n\nIn addition to detailed clinical data collection, the study incorporates biospecimen acquisition, when clinically indicated and feasible, including peripheral blood and organ-specific specimens (e.g., bronchoalveolar lavage fluid for ICI-related pneumonitis, liver biopsy tissue for ICI-related hepatitis, and other relevant clinical specimens). These samples will support exploratory immunologic and molecular analyses to better understand mechanisms underlying irAE development, resolution, and recurrence after rechallenge.\n\nThis study is designed to generate real-world evidence to improve risk stratification, toxicity management, and decision-making regarding immunotherapy continuation or re-initiation.",[23],"RECRUITING","2026-03-01",{"date":49,"type":28},"2026-03-06",{"date":51,"type":28},"2023-01-01",{"date":53,"type":19},"2033-12-31",{"name":55,"class":35},"Peking Union Medical College Hospital",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":56},"100626049","adebrelimab-combined-with-chemotherapy-for-the-esophageal-squamous-cell-carcinoma-100626049","NCT07430579","Adebrelimab Combined With Chemotherapy for the Esophageal Squamous Cell Carcinoma","A Single-arm, Single-center, Exploratory Clinical Study of Adebrelimab Combined With Neoadjuvant Chemotherapy for the Treatment of Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Patients must have a histopathologically confirmed diagnosis of Esophageal Squamous Cell Carcinoma （ESCC）.\n2. Eligible patients are those with stage II\u002FIII disease according to the AJCC\u002FUICC 8th edition Tumor-Node-Metastasis (TNM) staging system, presenting with cT1-3N1-2M0 or cT3-4aN0M0 disease.\n3. Patients could tolerate chemotherapy and surgery after evaluation and MDT discussion, accepting the clinical trial protocol.\n\nExclusion Criteria:\n\n1. Patients with a history of other uncured malignancies within the past 5 years, individuals with ongoing or a history of autoimmune diseases, and those who have received any prior anti-tumor therapy.\n2. Patients' cardio- pulmonary function could not tolerate surgery or chemotherapy, or don't accept the clinical trial protocol.","80 Years",{"count":66,"type":19},25,"INTERVENTIONAL",[69],"NA","This study is a prospective, single-arm, phase II exploratory clinical trial. The primary endpoint of this study is to evaluate the pathological complete response (pCR) rate after surgery and to assess the safety of neoadjuvant therapy with adebrelimab combined with platinum-based chemotherapy in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC) at the Second Qilu Hospital of Shandong University.\n\nThe primary endpoint of this clinical trial is the pathological complete response (pCR) rate, defined as the absence of residual viable tumor cells in the resected specimen, including lymph nodes (ypT0N0M0). Secondary endpoints include the major pathological response (MPR) rate, objective response rate (ORR), treatment-related adverse events (TRAEs) and immune-related adverse events (irAEs), as well as quality of life (QOL) assessments during neoadjuvant immunochemotherapy (nICT). MPR is defined as less than 10% residual viable tumor cells in the primary tumor bed following neoadjuvant therapy and resection. ORR represents the percentage of patients achieving complete response (CR) or partial response (PR). Other secondary measures include the tumor downstaging rate, surgery rate, R0 resection rate (defined as no residual tumor at the resection margins), and perioperative complication rate. Furthermore, overall survival (OS) and relapse-free survival (RFS) are considered exploratory endpoints in this study. By evaluating these diverse endpoints, the investigators aim to comprehensively assess the efficacy, safety, and overall impact of the nICT approach in patients with locally advanced resectable ESCC. Additionally, it is planned to construct 20 pairs of esophageal squamous cell carcinoma and adjacent normal esophageal squamous epithelial organoids, laying the groundwork for future in-depth exploration of the mechanisms underlying esophageal carcinogenesis and progression, as well as functional studies of specific genes.",[72,73,74,75],"Pathological Complete Remission","Objective Response Rate","Immune-related Adverse Events","Quality of Life","2026-02-23",{"date":78,"type":28},"2026-02-24",{"date":80,"type":28},"2024-12-09",{"date":82,"type":19},"2028-06-30",{"name":84,"class":35},"The Second Hospital of Shandong University",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100620439","longitudinal-cohort-study-of-immune-related-adverse-events-in-solid-tumor-patients-treated-with-immune-checkpoint-inhibitors-100620439","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",{"count":93,"type":19},940,"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.",[96,23,97],"Solid Tumor","Immunotherapy Toxicity",[99,100,101,102,103,104,105],"Immune checkpoint inhibitors","Immunotherapy","Biomarkers","Neurotoxicity","Neuroimmune adverse events","immune related adverse events","PD-1 blocker","2026-01-26",{"date":108,"type":28},"2026-01-28",{"date":110,"type":28},"2019-01-10",{"date":112,"type":19},"2029-09-10",{"name":114,"class":35},"Shantou University Medical College",6,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":124,"targetDuration":126,"studyType":20,"phases":4,"briefSummary":127,"conditions":128,"keywords":134,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":56},"100612090","interferon-signature-in-anti-ctla-4-and-anti-pd-1pd-l1-treated-cancer-patients-compared-with-systemic-autoimmune-disease-patients-100612090","NCT07249060","Interferon Signature in Anti-CTLA-4 and Anti-PD-1\u002FPD-L1-Treated Cancer Patients Compared With Systemic Autoimmune Disease Patients","Interferon Signature in Cancer Patients Treated With Anti-CTLA-4 and Anti-PD-1\u002FPD-L1 Therapies: A Multicenter, Prospective, Observational Cohort Study Comparing Cancer Patients and Non-Cancer Patients With Systemic Autoimmune Diseases","INTER-AUTENTIC","ICI cohort:\n\nInclusion Criteria:\n\n* Initiation of treatment with a single ICI or dual ICI therapy in accordance with current clinical guidelines;\n* Patients who are treatment-naïve to ICIs; and\n* Age ≥18 years.\n\nExclusion Criteria:\n\n* Estimated mortality of less than 3 months from the start of treatment;\n* Current combination therapy with chemotherapy, tyrosine kinase inhibitors, or other tumor-specific treatments;\n* Contraindication to treatment with ICIs (documented hypersensitivity, severe active autoimmune disease, Eastern Cooperative Oncology Group \\[ECOG\\] ≥3);\n* Ongoing immunosuppressive therapy, including prednisone at doses \\>10 mg\u002Fday or equivalent.\n\nSAD cohort:\n\nInclusion Criteria:\n\n* Meeting classification criteria for Systemic Lupus Erythematosus (SLE) (ACR\u002FEULAR 2019), Primary Sjögren's Syndrome (pSS) (ACR\u002FEULAR 2016), Systemic Sclerosis (SSc) (ACR\u002FEULAR 2013), and\u002For Idiopathic Inflammatory Myopathy (IIM) (ACR\u002FEULAR 2017).\n* Age ≥18 years old.\n\nExclusion Criteria:\n\n* Estimated mortality less than 3 months from the start of follow-up.\n* Active immunosuppressive treatment, including prednisone at doses \\>10 mg\u002Fday or equivalent.\n* Recent diagnosis (\\\u003C1 year) of cancer, with the exception of non-melanoma skin cancer, or currently receiving active oncology-specific treatment.",{"count":125,"type":19},300,"48 Weeks","This study aims to identify a way to predict the side effects that some people with cancer experience when receiving immunotherapy. These side effects, known as immune-related adverse events (irAEs), occur when the immune system mistakenly attacks healthy tissues, like certain autoimmune diseases. At present, clinicians lack reliable tests to determine who is most likely to develop these reactions. The goal of this study is to determine whether substances in the blood called interferons (IFNs) could serve as early warning markers.\n\nThe study will include 300 people with cancer who are about to begin immunotherapy. To provide a meaningful comparison, the investigators will also enroll 40 individuals with autoimmune diseases such as lupus. Understanding how IFN levels differ between these groups may help clarify whether IFN patterns in cancer patients resemble those seen in autoimmune disease.\n\nParticipants in both groups will be asked to provide small blood samples at predefined time points during their clinical care or treatment. Researchers will measure the levels of different IFN types in all samples to compare IFN levels between cancer patients and individuals with autoimmune diseases, and within the cancer group between patients who develop irAEs and those who do not. The long-term aim of the study is to develop a simple test that can help clinicians identify patients at higher risk of irAEs.\n\nImmune-related adverse events (irAEs) are a frequent complication in cancer patients treated with immune checkpoint inhibitors (ICIs), and they often resemble or exacerbate preexisting autoimmune diseases. Despite extensive research in the field, no validated predictive biomarkers of irAEs currently exist. Emerging evidence suggests that the IFN signature -long implicated in the pathogenesis of several systemic autoimmune diseases (SADs)- may also be upregulated in patients who develop ICI-induced irAEs, likely with substantial overlap among different IFN subtypes. Given these clinical and molecular similarities with SADs, it is plausible that IFN levels in peripheral blood carry predictive value for irAE risk, although the dominant IFN types in ICI-related toxicity remain unknown.\n\nThe INTER-AUTENTIC project aims to determine whether baseline IFN levels and their dynamic changes, measured in peripheral blood using a dedicated panel, can predict the onset of irAEs in cancer patients receiving ICIs. Supported by the Medical Oncology departments of six university hospitals in Northern Spain, this multicenter, observational, prospective cohort study has been underway since 2021. Biobank samples have been collected from ICI-treated patients before treatment initiation, at protocol-defined time points, and at the moment of irAE diagnosis (ICI cohort). The study seeks to identify the IFN subtypes with the most pronounced differential expression between patients with and without irAEs, and to evaluate whether IFN levels enhance the predictive performance of a model incorporating other clinical variables potentially associated with immune-mediated toxicity. A sample size of 300 cancer patients has been estimated for this analysis.\n\nIn addition, a second prospective cohort of 40 non-cancer patients with systemic lupus erythematosus, primary Sjögren's syndrome, systemic sclerosis, and\u002For idiopathic inflammatory myopathy (SAD cohort) will be included. Since IFNs play a well-established pathogenic role in these conditions, this cohort will allow characterization of the IFN signature at key follow-up points (baseline, remission, and disease flare) and comparison with the IFN profiles of ICI-treated patients, regardless of whether they develop irAEs.",[23,129,130,131,132,133],"Lupus Erythematosus, Systemic","Sjogren Syndrome","Systemic Sclerosis (SSc)","Inflammatory Myopathies","Solid Tumors",[135,136,101,137,138,139],"Immune Checkpoint Inhibitors","Adverse events","Predictive","Prospective Studies","Immune System","2025-11-25",{"date":142,"type":28},"2025-12-03",{"date":144,"type":28},"2024-01-08",{"date":146,"type":19},"2026-12",{"name":148,"class":35},"Hospital Universitario Araba",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":157,"targetDuration":159,"studyType":20,"phases":4,"briefSummary":160,"conditions":161,"keywords":165,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":179},"100605802","management-of-immune-checkpoint-inhibition-related-hepatitis-using-low-dose-corticosteroids-100605802","NCT07167251","Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids","Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids - A Prospective Registry-based, Cohort Study","MIRA-HEP","Inclusion Criteria:\n\n1. Cancer patients aged 18 years or older\n2. Treatment with a programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) antibody, or a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or a combination of a PD-1 and CTLA-4 antibody, or a PD-1 and lymphocyte-activation gene 3 (LAG-3) antibody\n3. Occurrence of immune-related hepatitis grade 2 to 3 (as per judgment of the investigator)\n4. Ability of the patient to comply with the study procedures (management of immune-related hepatitis)\n\nExclusion Criteria:\n\n1. Previous Immune-related hepatitis that required systemic therapy\n2. Treatment for Immune-related hepatitis has already been initiated with high-dose corticosteroids (\\>0.5 mg\u002Fkg body weight)\n3. Immune-related hepatitis with bilirubin \\> 1.5 ULN or clinical suspicion of cholangitis or elevated INR (beyond baseline)\n4. Immune-related hepatitis with grade 4 at first presentation\n5. Prior irAE treated with systemic immunosuppression\n6. Simultaneous immune-related neurological toxicity or immune-related myocarditis (since these usually have to be treated with high doses of corticosteroids)\n\n   a. Patients with other immune-related adverse events may be included according to the investigator's judgment\n7. Known liver disease (e.g., autoimmune hepatitis, active hepatitis B, C or E, hemochromatosis, liver cirrhosis Child-Pugh Score B or C, primary biliary cholangitis, primary biliary cirrhosis, Morbus Wilson)\n\n   a. Patients with liver metastasis are eligible\n8. Patients receiving cancer treatment other than immune checkpoint inhibitors in parallel (e.g., tyrosine kinase inhibitors or chemotherapy).\n\n   a. Patients who have received other cancer treatments in previous cycles are eligible, provided the treating physician does not assume any toxicity from the other medication.\n9. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to occurrence of IR hepatitis. Stable corticosteroid doses of \\\u003C 10mg prednisone equivalent are allowed.",{"count":158,"type":19},63,"6 Months","This study evaluates the effectiveness of low-dose corticosteroids in managing grade 2-3 immune-related hepatitis in cancer patients treated with immune checkpoint inhibitors. It aims to determine whether of 0.5-1miligram per kilogram bodyweight prednisolone is sufficient to manage immune-related hepatitis without the need for dose escalation or additional immunosuppressive therapy.",[162,163,164],"Immune Related Adverse Events","Immune-Mediated Hepatitis","Cancer",[166,167,168,169],"Immune-related adverse events","Immune checkpoint inhibitor","Immune-related hepatitis","immune-mediated hepatitis","2025-09-08",{"date":172,"type":28},"2025-09-11",{"date":174,"type":28},"2025-08-25",{"date":176,"type":19},"2026-12-31",{"name":178,"class":35},"University Hospital, Basel, Switzerland",2,{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":67,"phases":189,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":204,"leadSponsor":206,"locationsCount":179},"100576769","phase-1-evaluating-informatics-assisted-immune-related-adverse-event-detection-to-improve-registration-onto-a-biorepository-100576769","NCT06789601","Evaluating Informatics-assisted Immune-related Adverse Event Detection to Improve Registration Onto a Biorepository","A Non-Interventional Pragmatic Clinical Trial of NLP Models for the Detection of Immune-Related Adverse Events","Inclusion Criteria:\n\n* Received or receiving a regimen containing one or more immuno-oncology therapeutics",{"count":188,"type":19},100,[190,191],"PHASE1","PHASE2","Immunotherapies have improved cancer outcomes, but have a unique profile of immune-related adverse events (irAEs). Biorepositories have been established to collect data and samples to help improve our understanding of irAEs, however identifying patients who are eligible for these biorepositories in a timely fashion can be challenging. The goal of this study is to determine if an informatics system for automated irAE detection can improve registration to a prospective irAE biorepository (NCT04242095). The informatics system automatically \"reads\" participants' electronic health records (EHRs) and determines whether that patient may be experiencing an irAE. The main questions it aims to answer are:\n\n* Is it feasible to implement an informatics system for daily analysis of EHR data to detect irAEs?\n* Does the automated irAE detection system improve registration rates to an irAE biorepository at our institution following an eligible irAE?\n\nResearchers will compare standard irAE monitoring to informatics-assisted irAE monitoring to see if using the informatics system increases the registration rate and improves data entry efficiency and quality.\n\nParticipants will:\n\n* Be randomly assigned to standard monitoring or informatics-assisted monitoring for irAE detection.\n* Have their EHR reviewed to collect demographic, medical, and cancer treatment history.\n* Be monitored for irAEs through daily automated analysis of their EHR data for up to 12 months or until registration in the biorepository.",[194,162],"Malignancy",[196,197,198,199],"malignancy","adverse drug event","health informatics","natural language processing","2025-06-17",{"date":202,"type":28},"2025-06-19",{"date":200,"type":28},{"date":205,"type":19},"2027-08-31",{"name":207,"class":35},"Brigham and Women's Hospital",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":56},"100427003","multi-centre-prospective-non-interventional-study-to-intensively-monitor-the-safety-of-sintilimab-in-clinical-practice-among-chinese-patients-100427003","NCT04840355","Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Sintilimab in Clinical Practice Among Chinese Patients","Clinical Study on Multidimensional Prevention of Sintilimab Induced irAEs Based on GEP Pattern Recognition","Inclusion Criteria:\n\n1. Age ≥18 and ≤75 years old;\n2. Subjects with histologically or cytologically confirmed are prepared to receive Sintilimab treatment;\n3. Life expectancy of at least 6 months;\n4. Eastern Cooperative Oncology Group (ECOG) PS status≤ 2 or Karnofsky (KPS) ≥ 60;\n5. No prior immune checkpoint inhibitor treatment\n6. Signed written informed consent before any study-related procedure;\n7. Adequate hematopoietic function as defined by an absolute neutrophil count ≥1.5×109 \u002FL, platelet count≥80×109 \u002FL, hemoglobin≥90 g\u002FL\n8. Adequate hepatic function, defined as a total bilirubin level≤1.5 ×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 × ULN in subjects without liver metastases, AST and ALT levels ≤5 × ULN in subjects with documented liver metastases;\n9. Adequate renal function, defined as serum creatinine (Cr)≤1.5×ULN or calculated creatinine clearance≥60ml\u002Fmin (Cockcroft-Gault formula);\n10. Serum albumin ≥28g\u002FL;\n11. Thyroid-stimulating hormone (TSH)≤1×ULN (if abnormal,subject with the normal levels of FT3 and FT4 can be enrolled).\n\nExclusion Criteria:\n\n1. Has active autoimmune disease;\n2. Severe heart, lung, brain, kidney, gastrointestinal or systemic diseases;\n3. has interstitial lung disease;\n4. Simultaneous use of drugs that can affect the results of this study;\n5. Treatment may interfere with the results of the study\n6. Allergy or intolerance to the study drug\n7. subject with unconsciousness and psychiatric disorder\n8. Pregnant and lactating women\n9. Subject with poison and alcohol abuse","75 Years",{"count":188,"type":19},"In recent years, immunotherapy has become one of the important treatments for malignant tumors. Among them, PD-1 inhibitors have been widely used in clinical practice, and have shown a significant survival benefits in many patients. However, the incidence of immune-related adverse reactions (irAEs) of PD-1 inhibitors is relatively high, and severe cases can even threaten patients's life. At present, irAEs have become a bottleneck and it is urgent to establish a prevention strategy for the prediction of irAEs. In this study, the investigators intends to use Sintilimab as the research drug. A prospective cohort study was carried out. Part of the sample which was used as a training set would be detected for producing a time-series multi-dimensional data such as differential genes, metabolites and immune factors. Then gene expression programming (GEP) was used to explore the irAEs recognition model. Then, based on this recognition model, internal verification ( part of samples from the center 1 ) and external verification ( part of samples from the center 2 and center 3 samples) are carried out to accurately predict the high-risk population of irAEs and realize the early-stage warning of Sintilimab induced- irAEs.",[162,219],"PD-1","2024-12-22",{"date":222,"type":28},"2024-12-27",{"date":224,"type":28},"2021-02-26",{"date":226,"type":19},"2025-11-14",{"name":228,"class":35},"Guohui Li",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":235,"enrollmentInfo":236,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":56},"100424455","a-single-cell-approach-to-identify-biomarkers-of-pulmonary-toxicity-for-immune-checkpoint-blockade-100424455","NCT04807127","A Single-cell Approach to Identify Biomarkers of Pulmonary Toxicity for Immune Checkpoint Blockade","Inclusion criteria:\n\n* Adult M\u002FF\u002FX (\\>= 18 years)\n* Patients receiving or having received treatment per guidelines\n* Patients undergoing bronchoscopy with BAL, for possible cancer treatment-induced pneumonitis\n* Not included in other clinical trials\n* Signed informed consent form\n\nExclusion criteria:\n\n• Collected material not suitable for further processing in this study (e.g. bad quality). This decision will be made in consultation with a lab technician and\u002For bio-informatician, specialized in single-cell analysis.","120 Years",{"count":237,"type":19},60,"The main goal of this prospective non-interventional exploratory monocentric study is to characterize the immune cell composition of bronchoalveolar lavage (BAL) fluid from cancer patients experiencing cancer therapy-induced pneumonitis on a single-cell scale. These mechanistic insights can directly lead to putative diagnostic biomarkers and therapeutic targets.\n\nA second highly clinically relevant hypothesis is that single-cell profiling of blood samples will reveal circulating biomarkers of ICB toxicity, making non-invasive diagnosis feasible.",[240,100,74],"Pneumonitis, Interstitial","2024-06-28",{"date":243,"type":28},"2024-07-01",{"date":245,"type":28},"2020-02-01",{"date":247,"type":19},"2025-01-31",{"name":249,"class":35},"Universitaire Ziekenhuizen KU Leuven"]