RecruitingNCT04615988

Correlation Vitamin D Level to Endocrine Autoimmune Toxicity Due to Immune Checkpoint Inhibitors

Correlation of Serum Vitamin D Level With the Development of Endocrine Autoimmune Complications During Treatment With Immune Checkpoint Inhibitors


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

17 participants

Start Date

Jun 9, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether vitamin D levels affect the risk of developing hormone-related side effects (like thyroid problems) in cancer patients receiving immune checkpoint inhibitor drugs (a type of immunotherapy). It does not test a new treatment — it observes patients during their standard immunotherapy. **You may be eligible if...** - You have a cancer being treated with PD-1 or PD-L1 immune checkpoint inhibitor drugs - You are 18 or older - You are willing to complete symptom questionnaires and allow regular blood draws **You may NOT be eligible if...** - You already have a known thyroid condition (overactive or underactive thyroid) - Your hemoglobin is very low (below 9) - You are actively supplementing with vitamin D for a deficiency (routine multivitamins are okay) - You are pregnant or breastfeeding - You have a history of pituitary inflammation (hypophysitis) - You cannot attend all required study visits Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERblood draw and questionnaire completion

questionaires provided to subjects during visits while on study and baseline one tube of blood drawn

OTHERquestionnaire completion, blood collection

questionnaire provided to subject during study visits. One tube blood collected for research purposes at baseline


Locations(1)

Mount Sinai Hospital /Tisch Cancer Cancer/Ruttenberg Treatment Center

New York, New York, United States

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NCT04615988


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