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RECRUITING
NCT04615988

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

Sponsor: Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

17

Start Date

2021-06-09

Completion Date

2028-06

Last Updated

2026-03-27

Healthy Volunteers

No

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

Locations (1)

Mount Sinai Hospital /Tisch Cancer Cancer/Ruttenberg Treatment Center

New York, New York, United States