Correlation Vitamin D Level to Endocrine Autoimmune Toxicity Due to Immune Checkpoint Inhibitors
Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Oct 29, 2020
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at whether the level of vitamin D in a person's blood can affect their risk of developing thyroid problems while receiving a type of cancer treatment called immunotherapy. Immunotherapy helps the body’s immune system fight cancer but can sometimes cause issues with the thyroid, a gland that helps regulate many functions in the body. In this study, your cancer treatment will be the standard care chosen by your doctor, and researchers will take blood samples to measure vitamin D levels and check how well your thyroid is working. You will also fill out questionnaires about any symptoms you experience during the treatment.
To participate in this study, you need to be over 18 years old, have a specific type of cancer for which your doctor plans to use immunotherapy that blocks proteins known as PD-1 or PD-L1, and be willing to answer questions and have blood drawn. There are some criteria that would exclude you from participating, such as having a history of thyroid problems or being pregnant. If you meet the eligibility requirements, this study could help researchers learn more about the relationship between vitamin D and thyroid health in patients receiving immunotherapy.
Gender
ALL
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
About Icahn School Of Medicine At Mount Sinai
The Icahn School of Medicine at Mount Sinai is a premier academic institution located in New York City, renowned for its commitment to advancing medical research, education, and patient care. As a leading sponsor of clinical trials, the institution leverages its state-of-the-art facilities and multidisciplinary expertise to drive innovative research initiatives aimed at improving health outcomes. With a focus on translational medicine, the Icahn School of Medicine collaborates with a diverse network of researchers, clinicians, and industry partners to explore novel therapies and interventions across a wide range of medical disciplines. Its rigorous scientific approach and dedication to ethical standards position it as a trusted leader in the clinical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Patients applied
Trial Officials
Philip Friedlander, MD PhD
Principal Investigator
MOUNT SINAI HOSPITAL
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials