No Intervention: Observational Cohort: 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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Patients aged 18 or older years with a life expectancy of at least 6 months. Additional inclusion criteria were a Zubrod performance status of 0-1, documentation of baseline chest computed tomography (CT) scans prior to the initiation of immunotherapy, receipt of at least 2 cycles of systemic therapy (PD-1) as either monotherapy or combination therapy within the past six months, voluntary participation with written informed consent, and appropriate baseline biochemical tests. The radiation dose for thoracic radiotherapy was ≥30Gy for all eligible patients in this study. No use of antibiotics within 1 week prior to the initiation of thoracic radiotherapy.
Exclusion Criteria:Participation in other interventional clinical studies or treatments, having received investigational drugs or treatments within 4 weeks prior to the first dose, or prior receipt of a solid organ or hematopoietic stem cell transplant, having an active infection, or pre-existing/active ICI-induced pneumonitis.
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Primary outcome measure(s)
Area Under the Receiver Operating Characteristic Curve (AUC) of the Multi-Omics Prediction Model for Radiation Pneumonitis — At 6 months post-radiotherapy 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.
Trial sites (1)
Facility
City
Region
Status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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