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

NCT07131007 | Recruiting DMC

• 1 other identifier: 2024ZD0526105
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm; Organ Damage

Keywords

Tumor immunotherapy; Immune checkpoint inhibitors; Immune - related adverse events; organ damage

Outcome Measures

Primary Outcomes (1)

• Whether the patient has developed immune-related organ damage and the severity grade of such damage (if it occurs).

  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).

  1 month post - organ damage diagnosis

Secondary Outcomes (15)

• 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

Study Arms (1)

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.

Behavioral: Immunotherapy Monitoring and Sample Collection

Interventions

Immunotherapy Monitoring and Sample Collection BEHAVIORAL

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.

Tumor Immunotherapy Cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients receiving immune checkpoint inhibitor therapy, excluding those with active autoimmune disease, severe organ dysfunction, or active infection, to evaluate organ damage early - warning signals.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead
• The First Affiliated Hospital of Dalian Medical University: collaborator

Study Sites (1)

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Before medication administration and 7 days after medication administration, blood, urine, and feces of patients will be collected for multi - omics analysis.

MeSH Terms

Conditions

Neoplasms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 48 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 19, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 23, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)