RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2021-06-09
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04615988

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Willingness to complete symptom questionnaires
  3. * Willingness to allow blood draws
  4. * Ability to provide informed consent
  5. * Age \> 18 years old
  1. * History of clinical or subclinical hyperthyroidism or hypothyroidism
  2. * Hemoglobin \< 9
  3. * Inability to come for all study visits.
  4. * Actively on vitamin D supplementation due to vitamin D deficiency (As part of a multivitamin is not exclusionary)
  5. * Pregnant or lactating
  6. * History of hypophysitis

Contacts and Locations

Study Contact

Philip Friedlander, MD PhD
CONTACT
2128248588
philip.friedlander@mssm.edu
Emily Gallagher, MD
CONTACT
2122413422
emilygallagher@mssm.edu

Principal Investigator

Philip Friedlander, MD PhD
PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL

Study Locations (Sites)

Mount Sinai Hospital /Tisch Cancer Cancer/Ruttenberg Treatment Center
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Philip Friedlander, MD PhD, PRINCIPAL_INVESTIGATOR, MOUNT SINAI HOSPITAL

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-09
Study Completion Date2027-06

Study Record Updates

Study Start Date2021-06-09
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • vitamin D deficiency
  • immunotherapy with inhibitor of PD-1/L1
  • immune mediated thyroid toxicity

Additional Relevant MeSH Terms

  • Thyroid
  • PD-1
  • Cancer