A Study on Predictive Models & Clinical Outcome of Radiation Pneumonitis

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

1. 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. 2. 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). 3. Detect serum proteins, gene expression profile, single-nucleotide polymorphisms, and epigenetic modifications that may be associated with radiation pneumonitis. 4. Screen biomarkers that are associated with radiation pneumonitis via univariate and multivariate Cox regression analysis. 5. Construct a predictive model of radiation pneumonitis based on clinical information, radiomics, and biomarkers via machine learning or Least absolute shrinkage and selection operator. 6. Use Kaplan-Meier and Cox model to analyze the association of radiation pneumonitis with survival and efficacy of antitumor treatment. 7. Identify biomarkers and predictors of other toxicities induced by radiotherapy including radiation esophagitis, cardiotoxicity and radiodermatitis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05448703
Study type	Observational
Source	Huazhong University of Science and Technology
Contact	Xianglin Yuan, PhD
Phone	+8613667241722
Email	yuanxianglin@hust.edu.cn
Status	Recruiting
Phase
Start date	February 25, 2021
Completion date	September 1, 2026

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms