NCT04615988 Correlation Vitamin D Level to Endocrine Autoimmune Toxicity Due to Immune Checkpoint Inhibitors
| NCT ID | NCT04615988 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Thyroid |
| Study Type | OBSERVATIONAL |
| Enrollment | 17 participants |
| Start Date | 2021-06-09 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 17 participants in total. It began in 2021-06-09 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * History of clinical or subclinical hyperthyroidism or hypothyroidism * Hemoglobin \< 9 * 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 * History of hypophysitis
Contact & Investigator
Philip Friedlander, MD PhD
PRINCIPAL INVESTIGATOR
MOUNT SINAI HOSPITAL
Frequently Asked Questions
Who can join the NCT04615988 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thyroid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04615988 currently recruiting?
Yes, NCT04615988 is actively recruiting participants. Contact the research team at philip.friedlander@mssm.edu for enrollment information.
Where is the NCT04615988 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT04615988 clinical trial?
NCT04615988 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Philip Friedlander, MD PhD at MOUNT SINAI HOSPITAL. The trial plans to enroll 17 participants.