Construction and Evaluation of Tumor Immunotherapy and Organ Damage Early Warning System Based on Multi-omics
- Conditions
- Organ Function Damage in Immune - Related Adverse Events (irAEs) Associated With Immune Checkpoint Inhibitors (ICIs) During Tumor Immunotherapy
- Registration Number
- NCT07131007
- Lead Sponsor
- Hebei Medical University Fourth Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 2000
Patients with cancer who are receiving immune checkpoint inhibitor treatment
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Active phase of severe autoimmune disease
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Severe organ dysfunction
- Presence of active infection ④ Pregnancy or lactation ⑤ Allergy to drug components
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Accuracy of Organ Damage Early - Warning System 1 month post - organ damage diagnosis
- Secondary Outcome Measures
Name Time Method Liver injury indicators such as Total Bilirubin (TBIL)，Alanine Aminotransferase（ALT）and Aspartate Aminotransferase（AST） 1 month Renal injury indicators such as Creatinine (Cr) and Neutrophil Gelatinase-Associated Lipocalin (NGAL) 1 month Myocardial injury indicators such as High-Sensitivity Troponin T (hs-cTnT) 1 month Lung injury indicators such as Krebs von den Lungen-6 (KL-6) 1 month Inflammatory indicators such as C-Reactive Protein (CRP), Interleukin-6 (IL-6) and Tumor Necrosis Factor-α (TNF-α) 1 month Metabolomics indicators such as hormone levels, cholesterol, triglycerides and blood glucose 1 month Multi-omics indicators such as microbiota composition changes and exosomal biomarkers 1 month