NCT04615988 · Icahn School of Medicine at Mount Sinai
Correlation Vitamin D Level to Endocrine Autoimmune Toxicity Due to Immune Checkpoint Inhibitors
What this study is about
The purpose of this research study is to see if the amount of vitamin D in ones blood makes it more or less likely to develop thyroid gland toxicity when being treated with immunotherapy that blocks the activity of proteins called programed death-1(PD-1) or programmed death ligand-1 (PD-L1). Immunotherapy is treatment that makes changes to the immune system to try to fight cancer.
View original scientific description
The purpose of this research study is to see if the amount of vitamin D in ones blood makes it more or less likely to develop thyroid gland toxicity when being treated with immunotherapy that blocks the activity of proteins called programed death-1(PD-1) or programmed death ligand-1 (PD-L1). Immunotherapy is treatment that makes changes to the immune system to try to fight cancer. Immunotherapy treatments that block the activity of important parts of the immune system called PD-1 and PD-L1 are used to standardly treat many different types of cancer and can cause thyroid toxicity in certain people. In this study the treatment for your cancer is not research treatment but standard of care determined by your oncologist. Blood will be drawn before starting treatment to determine the amount of Vitamin D and also to assess thyroid function. Also questionnaires will be completed before starting treatment and while on treatment to assess symptoms you are experiencing.
Interventions
OTHER
blood draw and questionnaire completion
questionaires provided to subjects during visits while on study and baseline one tube of blood drawn
OTHER
questionnaire completion, blood collection
questionnaire provided to subject during study visits. One tube blood collected for research purposes at baseline
Primary outcome measures
Number of participants with risk of developing autoimmune thyroid disease treated with single agent.
Time frame: 20 weeks
Number of participants with risk of developing autoimmune thyroid disease in cancer treated with single agent anti-PD-1/PD-L1 therapy with baseline pre-treatment vitamin D deficiency compared with those with normal vitamin D levels
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations