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NCT Number: NCT07131007

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location status: Recruiting

Location contact

Liulixia LLX Liu, Doctorate

CONTACT

[email protected]

13833186570

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

    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 outcomes

  1. Liver injury indicators :Total Bilirubin (TBIL)

    Time frame: 1 month

  2. Liver injury indicators :Aspartate Aminotransferase(AST)

    Time frame: 1 month

  3. Liver injury indicators :Alanine Aminotransferase(ALT)

    Time frame: 1 month

  4. Renal injury indicators: Creatinine (Cr)

    Time frame: 1 month

  5. Renal injury indicators: Neutrophil Gelatinase-Associated Lipocalin (NGAL)

    Time frame: 1 month

  6. Myocardial injury indicators :High-Sensitivity Troponin T (hs-cTnT)

    Time frame: 1 month

  7. Lung injury indicators : Krebs von den Lungen-6 (KL-6)

    Time frame: 1 month

  8. Inflammatory indicators: C-Reactive Protein (CRP)

    Time frame: 1 month

  9. Inflammatory indicators:Interleukin-6 (IL-6)

    Time frame: 1 month

  10. Inflammatory indicators: Tumor Necrosis Factor-α (TNF-α)

    Time frame: 1 month

  11. Metabolomics indicators :hormone levels

    Time frame: 1 month

  12. Metabolomics indicators :cholesterol

    Time frame: 1 month

  13. Metabolomics indicators :triglycerides

    Time frame: 1 month

  14. Metabolomics indicators :blood glucose

    Time frame: 1 month

  15. Multi-omics indicators : microbiota composition changes

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Hebei Medical University Fourth Hospital

Other

Collaborators

  • The First Affiliated Hospital of Dalian Medical University

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Aug 19, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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