Correlation of Serum Vitamin D Level with the Development of Endocrine Autoimmune Complications During Treatment with Immune Checkpoint Inhibitors

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Mount Sinai Hospital /Tisch Cancer Cancer/Ruttenberg Treatment Center
RECRUITING
New York
Contact Information
Primary
Philip Friedlander, MD PhD
philip.friedlander@mssm.edu
2128248588
Backup
Emily Gallagher, MD
emilygallagher@mssm.edu
2122413422
Time Frame
Start Date: 2021-06-09
Estimated Completion Date: 2027-06
Participants
Target number of participants: 16
Treatments
Participants being treated with immunotherapy
Participants who are to receive standard of care immunotherapy targeting PD-1 or PDL1 as treatment for malignancy
Related Therapeutic Areas
Sponsors
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov