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
1 other identifier
observational
300
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2021
CompletedFirst Submitted
Initial submission to the registry
July 1, 2022
CompletedFirst Posted
Study publicly available on registry
July 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
October 6, 2022
October 1, 2022
5.5 years
July 1, 2022
October 5, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Other injuries induced by radiotherapy
5 years after radiotherapy
Study Arms (1)
Group 1
Lung cancer patients treated with thoracic radiotherapy
Interventions
blood sample to be taken at baseline, during radiotherapy, and after radiotherapy
Eligibility Criteria
Lung cancer patients treated with thoracic radiotherapy.
You may qualify if:
- Clinical diagnosis of lung cancer by histology
- Radiation dose at least 45 Gy
- Karnofsky \>60
- Age\>18
- Life expectancy of at least 6 months
You may not qualify if:
- Previous thoracic irradiation
- Severe cardiopulmonary diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 43000, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Jingjiang People' Hospital
Jingjiang, Jiangsu, 214500, China
Biospecimen
From peripheral blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xianglin Yuan, PhD
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Chief Physician
Study Record Dates
First Submitted
July 1, 2022
First Posted
July 7, 2022
Study Start
February 25, 2021
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
October 6, 2022
Record last verified: 2022-10