Actively Recruiting

Age: 18Years +
All Genders
NCT04615988

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

Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-03-27

17

Participants Needed

1

Research Sites

364 weeks

Total Duration

On this page

AI-Summary

What this Trial 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. 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Malignancy requiring PD-1 or PD-L1 inhibitor as the only immunotherapy for next treatment
  • Willingness to complete symptom questionnaires
  • Willingness to allow blood draws
  • Ability to provide informed consent
  • Age over 18 years old
Not Eligible

You will not qualify if you...

  • History of clinical or subclinical hyperthyroidism or hypothyroidism
  • Hemoglobin level less than 9
  • Inability to attend all study visits
  • Currently taking vitamin D supplements for vitamin D deficiency (multivitamin use allowed)
  • Pregnant or lactating
  • History of hypophysitis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

P

Philip Friedlander, MD PhD

CONTACT

E

Emily Gallagher, MD

CONTACT

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