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

NCT04615988 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Philip Friedlander, MD PhD · MOUNT SINAI HOSPITAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-09
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04615988 on ClinicalTrials.gov