A Multicenter Prospective Observational Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis

What this Trial Is About

This research focuses on lung cancer patients receiving thoracic radiotherapy, aiming to study radiation pneumonitis, a common side effect that can limit treatment dose and affect quality of life, survival, and therapy outcomes. The study seeks to identify biomarkers such as serum proteins, gene expression, genetic and epigenetic changes that influence radiation pneumonitis. It also examines the connection between radiation pneumonitis and other radiotherapy-related toxicities, and evaluates survival and treatment effectiveness in affected patients. Participants are observed in a multicenter prospective design where clinical information, CT images, and blood samples are collected before, during, and after radiotherapy. Follow-up visits occur during and one month after treatment, then every three months for the first year, and every six months afterward. Biomarker detection includes serum proteins, gene profiles, genetic variants, and epigenetic markers. Statistical models and machine learning techniques are used to build predictive models of radiation pneumonitis and to analyze its relationship with survival and treatment outcomes. During the study, patients undergo chest CT scans and clinical assessments at scheduled follow-ups to monitor radiation pneumonitis and other toxicities graded by oncologists. Researchers collect data on survival status, symptoms, and treatment throughout up to five years. The main outcomes measured are radiation pneumonitis incidence 12 months post-radiotherapy and overall survival at five years. Secondary outcomes include other radiotherapy-induced injuries. This long-term monitoring helps understand and predict adverse effects of thoracic radiotherapy in lung cancer patients.

A Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis