irAE Prediction of Anti-PD-1/L1 in Lung Cancer
Immunological Biomarkers for Immune-related Adverse Events of Anti-PD-1/PD-L1 Immunotherapy in Lung Cancer: a Prediction Model
1 other identifier
observational
120
1 country
1
Brief Summary
the purpose of this study is to identify multi-dimensional immunological biomarkers including cytokines, autoantibodies, and immune cell subtypes of immune-related adverse events (primary) and prognosis(secondary) in the anti-PD-1/anti-PD-L1 immunotherapy for lung cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2022
CompletedFirst Submitted
Initial submission to the registry
March 11, 2022
CompletedFirst Posted
Study publicly available on registry
March 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedApril 7, 2023
March 1, 2023
1.6 years
March 11, 2022
April 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
occurrence of immune-related adverse event (irAE)
Any adverse events occured within 12 months since immunotherapy initiation will be independently evaluated by two clinicians to determine whether it is irAE and all the clinical characteristics of irAE will be documented
12 months since immunotherapy initiation
Secondary Outcomes (2)
Overall Survival
24 months since immunotherapy initiation
Progression Free Survival.
24 months since immunotherapy initiation
Eligibility Criteria
Patients at a national tertiary referral center for lung cancer treatment
You may qualify if:
- years of age
- Stage I-IV Lung Cancer confirmed by histopathology or imaging techniques
- Receiving anti-PD-1/anti-PD-L1 immunotherapy (with indication and no contraindication)
You may not qualify if:
- Other cancer treatment
- Other malignancies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, China
Related Publications (1)
Yang H, Yao Z, Zhou X, Zhang W, Zhang X, Zhang F. Immune-related adverse events of checkpoint inhibitors: Insights into immunological dysregulation. Clin Immunol. 2020 Apr;213:108377. doi: 10.1016/j.clim.2020.108377. Epub 2020 Mar 2.
PMID: 32135278BACKGROUND
Biospecimen
plasma and peripheral monocytes obtained from the peripheral blood sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Huaxia Yang
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2022
First Posted
March 21, 2022
Study Start
January 21, 2022
Primary Completion
September 1, 2023
Study Completion
September 1, 2024
Last Updated
April 7, 2023
Record last verified: 2023-03