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Clinical Trials/NCT05448703
NCT05448703
Recruiting
Not Applicable

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

Huazhong University of Science and Technology3 sites in 1 country300 target enrollmentFebruary 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Radiation Pneumonitis
Sponsor
Huazhong University of Science and Technology
Enrollment
300
Locations
3
Primary Endpoint
Radiation pneumonitis
Status
Recruiting
Last Updated
3 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
February 25, 2021
End Date
September 1, 2026
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xianglin Yuan

Professor, Chief Physician

Huazhong University of Science and Technology

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of lung cancer by histology
  • Radiation dose at least 45 Gy
  • Karnofsky \>60
  • Life expectancy of at least 6 months

Exclusion Criteria

  • Previous thoracic irradiation
  • Severe cardiopulmonary diseases

Outcomes

Primary Outcomes

Radiation pneumonitis

Time Frame: 12 months after radiotherapy

radiation pneumonitis grade \>=2 or 3 graded by CTCAE4.0. \[Time Frame: 12 months after radiotherapy\]

Overall Survival

Time Frame: 5 years after radiotherapy

A long-term follow up will be scheduled to allow a complete survival analysis.

Secondary Outcomes

  • Other injuries induced by radiotherapy(5 years after radiotherapy)

Study Sites (3)

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