A Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Radiation Pneumonitis
• Intervention / Treatment: Other: Blood Samples for Biomarkers

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Xianglin Yuan, PhD; Phone Number: +8613667241722; Email: yuanxianglin@hust.edu.cn
• Study Contact Backup: Name: Lingyan Xiao, MD; Phone Number: +8615971474885; Email: lingyan.xiao123@gmail.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Xianglin Yuan, PhD; Phone Number: +8613667241722; Email: yuanxianglin@hust.edu.cn
      • Contact: Lingyan Xiao, MD; Phone Number: +8615971474885; Email: lingyan.xiao123@gmail.com
      • Principal Investigator: Xianglin Xianglin, PhD
    • Wuhan, Hubei, China, 43000
      • Recruiting
      • Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Guang Han, PhD; Phone Number: +8613886048178; Email: hg7913@hotmail.com
      • Contact: Ying Li, MD; Phone Number: +8613628635363; Email: hbwhw08@163.com
  • Jiangsu
    • Jingjiang, Jiangsu, China, 214500
      • Recruiting
      • Jingjiang People' Hospital
      • Contact: Dewen Wang, Bachelor; Phone Number: +8613815985599; Email: jsjjwdw@163.com
      • Contact: Lihua Fan, MD; Phone Number: +8613852619599; Email: 980692748@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Lung cancer patients treated with thoracic radiotherapy.

Description

Inclusion Criteria:

1. Clinical diagnosis of lung cancer by histology
2. Radiation dose at least 45 Gy
3. Karnofsky >60
4. Age>18
5. Life expectancy of at least 6 months

Exclusion Criteria:

1. Previous thoracic irradiation
2. Severe cardiopulmonary diseases

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Lung cancer patients treated with thoracic radiotherapy	Other: Blood Samples for Biomarkers; blood sample to be taken at baseline, during radiotherapy, and after radiotherapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Collaborators: Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology; Jingjiang People' Hospital
• Investigators: Principal Investigator: Xianglin Yuan, PhD, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 25, 2021
• Primary Completion (ANTICIPATED): September 1, 2026
• Study Completion (ANTICIPATED): September 1, 2026

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 2, 2022
• First Posted (ACTUAL): July 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Lung Diseases, Interstitial; Lung Injury; Radiation Injuries; Pneumonia; Radiation Pneumonitis
• Other Study ID Numbers: TJCC012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No