Construction and Evaluation of Tumor Immunotherapy and Organ Damage Early Warning System Based on Multi-omics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Whether the patient has developed immune-related organ damage and the severity grade of such damage (if it occurs).
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •· Patients with cancer who are receiving immune checkpoint inhibitor treatment.
排除标准
- •Active phase of severe autoimmune disease.
- •Severe organ dysfunction.
- •Presence of active infection.
- •Pregnancy or lactation.
- •Allergy to drug components.
研究组 & 干预措施
Tumor Immunotherapy Cohort
Cancer patients receiving immune checkpoint inhibitors (ICIs). We observe their clinical course, collect organ function data, and perform multi - omics analysis to construct an organ damage early - warning system.
干预措施: Immunotherapy Monitoring and Sample Collection (Behavioral)
结局指标
主要结局
Whether the patient has developed immune-related organ damage and the severity grade of such damage (if it occurs).
时间窗: 1 month post - organ damage diagnosis
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).
次要结局
- Inflammatory indicators：Interleukin-6 (IL-6)(1 month)
- Metabolomics indicators ：cholesterol(1 month)
- Multi-omics indicators ： microbiota composition changes(1 month)
- Metabolomics indicators ：triglycerides(1 month)
- Metabolomics indicators ：blood glucose(1 month)
- Liver injury indicators ：Total Bilirubin (TBIL)(1 month)
- Liver injury indicators ：Aspartate Aminotransferase（AST）(1 month)
- Liver injury indicators ：Alanine Aminotransferase（ALT）(1 month)
- Renal injury indicators： Creatinine (Cr）(1 month)
- Renal injury indicators： Neutrophil Gelatinase-Associated Lipocalin (NGAL)(1 month)
- Myocardial injury indicators ：High-Sensitivity Troponin T (hs-cTnT)(1 month)
- Lung injury indicators ： Krebs von den Lungen-6 (KL-6)(1 month)
- Inflammatory indicators： C-Reactive Protein (CRP)(1 month)
- Inflammatory indicators： Tumor Necrosis Factor-α (TNF-α)(1 month)
- Metabolomics indicators ：hormone levels(1 month)