NCT04615988Recruiting
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
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 17 (estimated)
- First submitted
- 29 Oct 2020
- Start date
- 9 Jun 2021
- Primary completion date
- Jun 2028
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- NCT number
- NCT04615988
What you commit to
- Study type: Observational
- Planned participants: 17
- From 9 Jun 2021 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of clinical or subclinical hyperthyroidism or hypothyroidism
- History of hypophysitis
Lab values
- Hemoglobin \< 9
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai Hospital /Tisch Cancer Cancer/Ruttenberg Treatment Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.