Actively Recruiting
Study of How Vitamin D Levels Affect Risk of Thyroid Autoimmune Problems During Cancer Immunotherapy Blocking PD-1 or PD-L1
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-03-27
17
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating whether blood levels of vitamin D affect the likelihood of developing thyroid gland toxicity in patients treated with immunotherapy drugs that block PD-1 or PD-L1 proteins. These immunotherapy treatments adjust the immune system to fight cancer but can cause immune-related side effects, including thyroid problems. The study focuses on patients receiving standard immunotherapy care for various cancers and aims to understand the connection between vitamin D levels and thyroid issues during treatment. Participants will receive their cancer treatment as determined by their doctor, which may include drugs like nivolumab, pembrolizumab, or ipilimumab. The study involves collecting blood samples before treatment to measure vitamin D and thyroid function, along with completing questionnaires about symptoms before and during treatment. Different immunotherapy regimens, including single agents and combination therapies, are part of standard care but not experimental treatments in this study. During the study, participants will have blood drawn at baseline and complete symptom questionnaires to monitor thyroid function and immune-related side effects up to 20 weeks. Researchers will assess the development of autoimmune thyroid disease and correlate it with vitamin D levels. The study includes safety monitoring, symptom tracking, and physician assessments to better understand immune toxicity risks. Participation duration and follow-up are planned according to treatment timelines and study visits.
CONDITIONS
Brief Title
Correlation Vitamin D Level to Endocrine Autoimmune Toxicity Due to Immune Checkpoint Inhibitors
Research Team
P
Philip Friedlander, MD PhD
E
Emily Gallagher, MD
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