Actively Recruiting
Correlation of Serum Vitamin D Level With the Development of Endocrine Autoimmune Complications During Treatment With Immune Checkpoint Inhibitors
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-03-27
17
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a malignancy for which your oncologist plans to treat you with PD-1 or PD-L1 blocking immunotherapy as your only immunotherapy
- Willing to complete symptom questionnaires
- Willing to allow blood draws
- Able to provide informed consent
- Are 18 years old or older
You will not qualify if you...
- History of clinical or subclinical hyperthyroidism or hypothyroidism
- Hemoglobin less than 9
- Unable to attend all study visits
- Currently taking vitamin D supplements specifically for vitamin D deficiency
- Pregnant or breastfeeding
- History of hypophysitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 20 weeks
Participants who are treated with standard immunotherapy targeting PD-1 or PD-L1 are observed for the development of immune-mediated thyroid toxicity. Questionnaires and blood samples are collected to assess vitamin D levels, symptoms, and thyroid antibodies.
Multiple visits during treatment for questionnaire completion and blood collection
Duration - Up to 24 weeks
Participants continue to be observed for changes in thyroid antibody levels and immune toxicity related to PD-1/PD-L1 treatment after initial monitoring.
Follow-up visits for questionnaire completion and blood collection
Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital /Tisch Cancer Cancer/Ruttenberg Treatment Center
New York, New York, United States, 10029
Actively Recruiting
Research Team
P
Philip Friedlander, MD PhD
E
Emily Gallagher, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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