Malignant Neoplasm, Organ Damage
Conditions
Keywords
Tumor immunotherapy, Immune checkpoint inhibitors, Immune - related adverse events, organ damage
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.
Interventions
BEHAVIORALImmunotherapy Monitoring and Sample Collection
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.
Sponsors
Hebei Medical University Fourth Hospital
The First Affiliated Hospital of Dalian Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
· Patients with cancer who are receiving immune checkpoint inhibitor treatment.
Exclusion criteria
* Active phase of severe autoimmune disease. * Severe organ dysfunction. * Presence of active infection. * Pregnancy or lactation. * Allergy to drug components.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whether the patient has developed immune-related organ damage and the severity grade of such damage (if it occurs). | 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). |
Secondary
| Measure | Time frame |
|---|---|
| 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：Interleukin-6 (IL-6) | 1 month |
| Inflammatory indicators： Tumor Necrosis Factor-α (TNF-α) | 1 month |
| Metabolomics indicators ：hormone levels | 1 month |
| Metabolomics indicators ：cholesterol | 1 month |
| Metabolomics indicators ：triglycerides | 1 month |
| Metabolomics indicators ：blood glucose | 1 month |
| Multi-omics indicators ： microbiota composition changes | 1 month |
Countries
China
Outcome results
None listed