A Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis

Study Overview
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Brief Summary
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Radiation pneumonitis is the main dose-limiting toxicity of thoracic radiotherapy, which can affect life quality, survival, and the tumor-controlling effects of patients receiving thoracic radiotherapy. The purpose of this study is to: Identify biomarkers including serum proteins, gene expression, genetic changes, and epigenetic modifications that determine radiation pneumonitis. Investigate the relationship between radiation pneumonitis and other toxicities induced by radiotherapy. Construct a predictive model for radiation pneumonitis. Evaluate survival and treatment outcome of patients with radiation pneumonitis.

Detailed Description
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Collect clinical information, CT images, and peripheral blood of the lung cancer patients treated with thoracic radiotherapy in Tongji Hospital, Hubei Cancer Hospital, and Jingjiang People's Hospital. Follow up the enrolled patients. All patients enrolled in this study are examined during and one month after radiotherapy. Then, the patients are followed every three months for the first year and every six months thereafter. At each follow-up visits, all patients are asked to undergo a chest CT, and information including survival status, symptoms, CT images, and treatment is collected. Radiation pneumonitis and other toxicities induced by radiotherapy are graded by two radiation oncologists according to the Common Terminology Criteria for Adverse Events 4.0 (CTCAE4.0). Detect serum proteins, gene expression profile, single-nucleotide polymorphisms, and epigenetic modifications that may be associated with radiation pneumonitis. Screen biomarkers that are associated with radiation pneumonitis via univariate and multivariate Cox regression analysis. Construct a predictive model of radiation pneumonitis based on clinical information, radiomics, and biomarkers via machine learning or Least absolute shrinkage and selection operator. Use Kaplan-Meier and Cox model to analyze the association of radiation pneumonitis with survival and efficacy of antitumor treatment. Identify biomarkers and predictors of other toxicities induced by radiotherapy including radiation esophagitis, cardiotoxicity and radiodermatitis.

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

Conditions
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Radiation Pneumonitis

Intervention / Treatment
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* Other: Blood Samples for Biomarkers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of lung cancer by histology Radiation dose at least 45 Gy Karnofsky >60 Age>18 Life expectancy of at least 6 months Exclusion Criteria: Previous thoracic irradiation Severe cardiopulmonary diseases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Lung cancer patients treated with thoracic radiotherapy | Other: Blood Samples for Biomarkers<br>* blood sample to be taken at baseline, during radiotherapy, and after radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation pneumonitis | radiation pneumonitis grade >=2 or 3 graded by CTCAE4.0. [Time Frame: 12 months after radiotherapy] | 12 months after radiotherapy | 
| Overall Survival | A long-term follow up will be scheduled to allow a complete survival analysis. | 5 years after radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other injuries induced by radiotherapy | Assessment of other common injuries induced by thoracic radiotherapy including injuries in heart, skin, and esophagus according to CTCAE4.0. | 5 years after radiotherapy |