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Longitudinal Cohort Study of Immune-Related Adverse Events in Solid Tumor Patients Treated With Immune Checkpoint Inhibitors

Recruitingn/aAges 18 Years - anyAllShantou University Medical College
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In plain words

What the trial is, and whether it could suit you

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. This 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 โ‰ฅ2 irAEs during follow-u

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 years * Histologically confirmed solid malignancy * Planned initiation of a new immune checkpoint inhibitor regimen (monotherapy or combination) as standard of care or on an approved clinical trial * Ability to provide informed consent * Baseline study assessments and biospecimen collection completed prior to first ICI dose * Life expectancy of at least 6 months as determined by treating oncologist * Availability of archival tumor tissue or willingness to undergo biopsy if archival tissue is unavailable Exclusion Criteria: * Uncontrolled medical, psychiatric, or social conditions that would interfere with study participation or data interpretation * Chronic systemic immunosuppression exceeding 10 mg/day prednisone equivalent within 14 days prior to enrollment (excluding inhaled, topical, or physiologic replacement doses) * Prior solid organ transplantation or allogeneic hematopoietic stem cell transplantation * Untreated, symptomatic, or progressing brain metastases (treated and stable brain metastases allowed if off systemic steroids for at least 7 days) * Inability or unwillingness to provide required baseline biospecimens
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What it tests

  • Not listed
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Where

6 sites
First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Hainan Hospital of Chinese PLA General Hospital
Sanya, China
Affiliated Cancer Hospital of Shantou University Medical College
Shantou, China
the First Affiliated Hospital of Shantou University Medical College
Shantou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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