A Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis

Radiation Pneumonitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05448703
• Other study ID #: TJCC012
• Status: Recruiting
• Start date: February 25, 2021
• Est. completion date: September 1, 2026

Study information

• Verified date: October 2022
• Source: Huazhong University of Science and Technology
• Contact: Xianglin Yuan, PhD
• Phone: +8613667241722
• Email: yuanxianglin[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Radiation Pneumonitis

Intervention

Other:
• Blood Samples for Biomarkers
blood sample to be taken at baseline, during radiotherapy, and after radiotherapy

Locations

Country	Name	City	State
China	Jingjiang People' Hospital	Jingjiang	Jiangsu
China	Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (3)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Jingjiang People' Hospital

Country where clinical trial is conducted

China, 

Outcome

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