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

• Sponsor: Huazhong University of Science and Technology (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05448703
• Collaborator: Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology (Other), Jingjiang People' Hospital (Other)
• Enrollment: 300
• Locations: 3
• Anticipated Duration (Months): 66.2
• Patients Per Site: 100
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radiation Pneumonitis	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 Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Multicenter Prospective Observational Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis
• Actual Study Start Date: Feb 25, 2021
• Anticipated Primary Completion Date: Sep 1, 2026
• Anticipated Study Completion Date: Sep 1, 2026

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Radiation pneumonitis [12 months after radiotherapy]

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

2. Overall Survival [5 years after radiotherapy]

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

Secondary Outcome Measures

1. Other injuries induced by radiotherapy [5 years after radiotherapy]

   Assessment of other common injuries induced by thoracic radiotherapy including injuries in heart, skin, and esophagus according to CTCAE4.0.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	43000
2	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430030
3	Jingjiang People' Hospital	Jingjiang	Jiangsu	China	214500

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Xianglin Yuan, PhD, Tongji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xianglin Yuan, Professor, Chief Physician, Huazhong University of Science and Technology
• ClinicalTrials.gov Identifier: NCT05448703
• Other Study ID Numbers: TJCC012
• First Posted: Jul 7, 2022
• Last Update Posted: Jul 7, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumonia; Radiation Pneumonitis

Study Results

No Results Posted as of Jul 7, 2022