Examining the link between vitamin D levels and thyroid toxicity in cancer immunotherapy
Official title: Correlation of Serum Vitamin D Level With the Development of Endocrine Autoimmune Complications During Treatment With Immune Checkpoint Inhibitors
Run by Icahn School of Medicine at Mount Sinai · NCT04615988 · Data updated 2026-11-12
This study is trying to see if having low vitamin D levels affects the chances of developing thyroid problems in cancer patients receiving immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 17 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Drugs / interventions | immunotherapy, ipilimumab, nivolumab, pembrolizumab |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | June 9, 2021 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT04615988 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with malignancies being treated with PD-1 or PD-L1 inhibitors and who are willing to participate in blood draws and symptom assessments.
✕Probably not a fit
Patients with a history of thyroid disorders, those on vitamin D supplementation, or those unable to attend study visits may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate whether vitamin D levels in the blood influence the likelihood of developing thyroid gland toxicity in patients undergoing immunotherapy that targets PD-1 or PD-L1 proteins. Participants will have their blood drawn to measure vitamin D and assess thyroid function before starting standard cancer treatment. Additionally, they will complete questionnaires to report any symptoms experienced during the treatment. The study seeks to better understand the relationship between vitamin D deficiency and immune-mediated thyroid toxicity in cancer patients receiving immunotherapy.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk for thyroid toxicity, allowing for better management and treatment strategies.
How similar studies have gone: While the relationship between vitamin D and immune response is being explored, this specific correlation with thyroid toxicity in the context of PD-1/L1 inhibitors is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Malignancy which the treating oncologist plans for next treatment to inhibit PD-1or PD-L1 with the immune inhibitor being the only immunotherapy. Twenty-five subjects in a separate cohort will need for eligibility to be planned for treatment with anti-PD1/PD-L1 plus antri-CTLA-4 therapy. * Willingness to complete symptom questionnaires * Willingness to allow blood draws * Ability to provide informed consent * Age \> 18 years old Exclusion Criteria: * History of clinical or subclinical hyperthyroidism or hypothyroidism * Hemoglobin \< 9 * Inability to come for all study visits. * Actively on vitamin D supplementation due to vitamin D deficiency (As part of a multivitamin is not exclusionary) * Pregnant or lactating * History of hypophysitis
Where it's running
-
Mount Sinai Hospital /Tisch Cancer Cancer/Ruttenberg Treatment Center
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Philip Friedlander, MD PhD — Mount Sinai Hospital
- Study coordinator: Philip Friedlander, MD PhD
- Email: philip.friedlander@mssm.edu
- Phone: 2128248588
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.