Construction and Evaluation of Tumor Immunotherapy and Organ Damage Early Warning System Based on Multi-omics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immunotherapy Monitoring and Sample Collection.
- Who it may be relevant to
- Registry conditions: Malignant Neoplasm, Organ Damage. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Behavioral Immunotherapy 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.
Primary outcome measures
- Whether the patient has developed immune-related organ damage and the severity grade of such damage (if it occurs). [Time frame: 1 month post - organ damage diagnosis]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fourth Hospital of Hebei Medical University — Shijiazhuang
Identifiers
NCT: NCT07131007 · 2024ZD0526105