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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT04615988
Status
Recruiting
Apply to this trial

Conditions

  • Cancer
  • PD-1
  • Thyroid

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • blood draw and questionnaire completion — OTHER
    questionaires provided to subjects during visits while on study and baseline one tube of blood drawn
  • questionnaire completion, blood collection — OTHER
    questionnaire provided to subject during study visits. One tube blood collected for research purposes at baseline

Study Details

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.

Key Dates

Start date
Jun 9, 2021
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
17 participants (estimated)

Arms

  • Arm: Participants being treated with immunotherapy
    Participants who are to receive standard of care immunotherapy targeting PD-1 or PDL1 as treatment for malignancy

Primary Outcome Measure

Number of participants with risk of developing autoimmune thyroid disease treated with single agent. [ Time Frame: 20 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai Hospital /Tisch Cancer Cancer/Ruttenberg Treatment CenterNew YorkNew York10029
Philip Friedlander, MD PhD
[email protected]
2128248588
Philip Friedlander, MD PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Mount Sinai Hospital /Tisch Cancer Cancer/Ruttenberg Treatment Center· New York, NY

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