The Risk Factors for Acute Radiation Pneumonitis in Patients With Prior Receipt of Immune Checkpoint Inhibitors
1 other identifier
observational
250
1 country
1
Brief Summary
The purpose of this non-interventional study is to collect data on the risk factors for acute radiation pneumonitis in patients with prior receipt of immune checkpoint inhibitors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2022
CompletedFirst Posted
Study publicly available on registry
February 2, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2025
CompletedMarch 15, 2024
March 1, 2024
2.8 years
January 21, 2022
March 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of acute radiation pneumonitis (aRPs) in patients with prior receipt of immune checkpoint inhibitors.
All suspected diagnoses of pneumonitis (regardless of grade) were centrally reviewed by a multidisciplinary committee consisting of at least one radiologist, pulmonologist, and oncologist. CT (or PET-CT) imaging was reviewed for each patient, which was then compared to the radiation treatment plan; other causes such as infection or tumor progression had to be ruled out using the appropriate workup.
6 months after last-patient- radiation
Interventions
Cancer patients underwent thoracic intensity-modulated radiotherapy, previously received ICIs
Eligibility Criteria
All patients treated with the product will be enrolled in the investigation
You may qualify if:
- Pathologically or cytologically confirmed malignant tumor
- Cancer patients with previously received ICIs underwent thoracic intensity-modulated radiotherapy
You may not qualify if:
- Cancer patients did not receive immunotherapy before thoracic intensity-modulated radiotherapy
- Non-thoracic radiotherapy patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
January 21, 2022
First Posted
February 2, 2022
Study Start
June 1, 2022
Primary Completion
March 31, 2025
Study Completion
October 31, 2025
Last Updated
March 15, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share