Research for endocrinological disorders associated with immune checkpoint inhibitors
Not Applicable
Recruiting
- Conditions
- Cancer patients treated with immune checkpoint inhibitors
- Registration Number
- JPRN-UMIN000019024
- Lead Sponsor
- agoya University, School of Medicine
- Brief Summary
Of the 451 patients, 51 developed thyroid irAEs after immunotherapy [41 of 416 (9.9%) treated with PD-1-Ab, 0 of 8 (0%) treated with CTLA-4-Ab, and 10 of 27 (37.0%) treated with PD-1/CTLA-4-Abs]. The cumulative incidence of thyroid irAEs was significantly higher in patients who were positive vs negative for ATAs at baseline after both PD-1-Ab [28/87 (32.2%) vs 13/329 (4.0%), P < 0.001] and PD-1/CTLA-4-Abs [6/10 (60.0%) vs 4/17 (23.5%), P < 0.05] treatments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 451
Inclusion Criteria
Not provided
Exclusion Criteria
Cancer patients not treated with immune checkpoint inhibitors
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of endocrine adverse events after treatment with immune checkpoint inhibitors
- Secondary Outcome Measures
Name Time Method Changes in pituitary, thyroid, and diabetes hormones as well as the presence of anti-pituitary antibodies Findings of pituitary MRI