Multi-Omics Prediction of Radiation Lung Injury in Immunotherapy-Treated Lung Cancer Patients
1 other identifier
observational
160
1 country
1
Brief Summary
This prospective study aims to develop a multi-omics-based predictive model for radiation pneumonitis in lung cancer patients receiving sequential immunotherapy and thoracic radiotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2026
CompletedFirst Posted
Study publicly available on registry
August 3, 2026
CompletedStudy Start
First participant enrolled
August 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2028
Study Completion
Last participant's last visit for all outcomes
August 15, 2028
August 3, 2026
July 1, 2026
2 years
July 29, 2026
July 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area Under the Receiver Operating Characteristic Curve (AUC) of the Multi-Omics Prediction Model for Radiation Pneumonitis
The area under the ROC curve (AUC) will be calculated to evaluate the predictive performance of a multi-omics-based model-integrating genomic, transcriptomic, proteomic, and metabolomic data-for distinguishing lung cancer patients who develop grade ≥2 radiation pneumonitis from those who do not, following sequential immunotherapy and thoracic radiotherapy. Model performance will be assessed using bootstrap internal validation with 1,000 resamples to estimate optimism-corrected AUC.
At 6 months post-radiotherapy
Study Arms (1)
Lung Cancer Patients Receiving Sequential Immunotherapy and Thoracic Radiotherapy
Interventions
This study involves collection of peripheral blood, urine, and stool samples from lung cancer patients who have received immunotherapy followed by thoracic radiotherapy. Samples are obtained at baseline prior to the initiation of radiotherapy for comprehensive multi-omics profiling, including genomic, transcriptomic, proteomic, and metabolomic analyses. No therapeutic intervention is administered as part of this study.
Eligibility Criteria
This prospective observational cohort study will enroll adult patients with histologically confirmed lung cancer who have received prior immunotherapy and are scheduled to undergo thoracic radiotherapy. Participants will be recruited from the Department of Oncology at Hubei Cancer Hospital. Eligible patients must have no use of antibiotics within 1 week prior to radiotherapy initiation, with no active infection or uncontrolled comorbidities. The study aims to collect blood, urine, and stool samples at baseline for multi-omics profiling. A total of approximately 160 participants will be enrolled.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430079, China
Biospecimen
Blood, urine, and stool samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
July 29, 2026
First Posted
August 3, 2026
Study Start (Estimated)
August 15, 2026
Primary Completion (Estimated)
August 15, 2028
Study Completion (Estimated)
August 15, 2028
Last Updated
August 3, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share