NCT07131007 Construction and Evaluation of Tumor Immunotherapy and Organ Damage Early Warning System Based on Multi-omics
| NCT ID | NCT07131007 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hebei Medical University Fourth Hospital |
| Condition | Malignant Neoplasm |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2025-09-15 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Frequently Asked Questions
Who can join the NCT07131007 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Malignant Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07131007 currently recruiting?
Yes, NCT07131007 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hebei Medical University Fourth Hospital to inquire about joining.
Where is the NCT07131007 trial being conducted?
This trial is being conducted at Shijiazhuang, China.
Who is sponsoring the NCT07131007 clinical trial?
NCT07131007 is sponsored by Hebei Medical University Fourth Hospital. The trial plans to enroll 2,000 participants.