This project is based on the in-depth analysis and integration of multi-omics data, including but not limited to genomics, transcriptomics, proteomics, and metabolomics. It aims to construct a comprehensive early-warning system for organ function damage in immune-related adverse events (irAEs) associated with immune checkpoint inhibitors (ICIs) during tumor immunotherapy. The core objective of this system is to enhance the overall safety and efficacy of tumor immunotherapy. First, the project leverages a database to mine the differential omics data of tumor immunotherapy patients with combined organ dysfunction (including combined and non-combined severe infections) within the scope of this project. By integrating biochemical indicators and related hemodynamic data, it constructs a risk early-warning system for organ damage in patients undergoing tumor immunotherapy, while verifying its clinical value and guiding significance. The specific contents mainly include: capturing specific molecules of organ damage in severe patients after tumor immunotherapy, screening genes, proteins, and metabolic products related to organ damage (including the heart, lungs, brain, liver, kidneys, gastrointestinal tract, etc.), and identifying new specific organ damage biomarkers under different pathogenic factors such as tumor immunotherapy, infections, and irAEs. It collects general clinical information, biochemical indicators, and hemodynamic indicators, and combines multi-omics data to establish an organ damage prediction model. Machine learning algorithms are used for optimization to construct an early-warning system. Model optimization within the system will be carried out, along with prospective clinical research and multi-dimensional verification. By evaluating the accuracy and cost-effectiveness of the model, it provides decision-making support for clinicians and promotes the development of personalized treatment.
Study Type
OBSERVATIONAL
Enrollment
2,000
For cancer patients receiving immune checkpoint inhibitors (ICIs), we conduct behavioral monitoring: collect blood, urine, and feces samples before medication and 7 days after medication for multi - omics analysis. Monitor organ function indicators at 24 hours, 72 hours, and 1 week post - medication. No interference with standard ICI treatment; focus on observational data collection to construct an organ damage early - warning system.
Whether the patient has developed immune-related organ damage and the severity grade of such damage (if it occurs).
The severity of immune-related adverse events (irAEs) is graded in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, ranging from Grade 1 (mild symptoms) to Grade 5 (death).
Time frame: 1 month post - organ damage diagnosis
Liver injury indicators :Total Bilirubin (TBIL)
Time frame: 1 month
Liver injury indicators :Aspartate Aminotransferase(AST)
Time frame: 1 month
Liver injury indicators :Alanine Aminotransferase(ALT)
Time frame: 1 month
Renal injury indicators: Creatinine (Cr)
Time frame: 1 month
Renal injury indicators: Neutrophil Gelatinase-Associated Lipocalin (NGAL)
Time frame: 1 month
Myocardial injury indicators :High-Sensitivity Troponin T (hs-cTnT)
Time frame: 1 month
Lung injury indicators : Krebs von den Lungen-6 (KL-6)
Time frame: 1 month
Inflammatory indicators: C-Reactive Protein (CRP)
Time frame: 1 month
Inflammatory indicators:Interleukin-6 (IL-6)
Time frame: 1 month
Inflammatory indicators: Tumor Necrosis Factor-α (TNF-α)
Time frame: 1 month
Metabolomics indicators :hormone levels
Time frame: 1 month
Metabolomics indicators :cholesterol
Time frame: 1 month
Metabolomics indicators :triglycerides
Time frame: 1 month
Metabolomics indicators :blood glucose
Time frame: 1 month
Multi-omics indicators : microbiota composition changes
Time frame: 1 month
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