Construction and Evaluation of Tumor Immunotherapy and Organ Damage Early Warning System Based on Multi-omics

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Whether the patient has developed immune-related organ damage and the severity grade of such damage (if it occurs). [Срок оценки: 1 month post - organ damage diagnosis]

Вторичные конечные точки (12)

• Liver injury indicators ：Total Bilirubin (TBIL) [Срок оценки: 1 month]
• Liver injury indicators ：Aspartate Aminotransferase（AST） [Срок оценки: 1 month]
• Liver injury indicators ：Alanine Aminotransferase（ALT） [Срок оценки: 1 month]
• Renal injury indicators： Creatinine (Cr） [Срок оценки: 1 month]
• Renal injury indicators： Neutrophil Gelatinase-Associated Lipocalin (NGAL) [Срок оценки: 1 month]
• Myocardial injury indicators ：High-Sensitivity Troponin T (hs-cTnT) [Срок оценки: 1 month]
• Lung injury indicators ： Krebs von den Lungen-6 (KL-6) [Срок оценки: 1 month]
• Inflammatory indicators： C-Reactive Protein (CRP) [Срок оценки: 1 month]
• Inflammatory indicators：Interleukin-6 (IL-6) [Срок оценки: 1 month]
• Inflammatory indicators： Tumor Necrosis Factor-α (TNF-α) [Срок оценки: 1 month]
• Metabolomics indicators ：hormone levels [Срок оценки: 1 month]
• Metabolomics indicators ：cholesterol [Срок оценки: 1 month]

Критерии участия

Критерии включения

· Patients with cancer who are receiving immune checkpoint inhibitor treatment.

Критерии исключения

• Active phase of severe autoimmune disease.
• Severe organ dysfunction.
• Presence of active infection.
• Pregnancy or lactation.
• Allergy to drug components.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Fourth Hospital of Hebei Medical University — Shijiazhuang

Идентификаторы

NCT: NCT07131007 · 2024ZD0526105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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