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NCT04615988 · ClinicalTrials.gov registry record
Correlation Vitamin D Level to Endocrine Autoimmune Toxicity Due to Immune Checkpoint Inhibitors
A clinical trial of Cancer and Thyroid, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- 16
- Enrollment target
- 1
- Study location
NCT04615988: Recruiting study of Cancer and Thyroid, sponsored by Icahn School of Medicine at Mount Sinai.
NCT04615988 is a study of Cancer and Thyroid that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 16 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04615988, a study of Cancer and Thyroid, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- 16 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Number of participants with risk of developing autoimmune thyroid disease in cancer treated with single agent anti-PD-1/PD-L1 therapy with baseline pre-treatment vitamin D deficiency compared with those with normal vitamin D levels
Interventions
- OTHER blood draw and questionnaire completion
- OTHER questionnaire completion, blood collection
Study Locations (1)
New York
- Mount Sinai Hospital /Tisch Cancer Cancer/Ruttenberg Treatment Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-06-09 |
| Est. Completion | 2027-06 |
What NCT04615988 shows while recruiting
NCT04615988 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which blood draw and questionnaire completion is the first listed.
NCT04615988 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04615988 about?
NCT04615988 is a clinical study titled "Correlation Vitamin D Level to Endocrine Autoimmune Toxicity Due to Immune Checkpoint Inhibitors". 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). Immunot...
What is the current status of trial NCT04615988?
This trial is currently recruiting. The enrollment target is 16 participants. The study started on 2021-06-09. Estimated completion is 2027-06.
What conditions does trial NCT04615988 study?
This clinical trial studies the following conditions: Cancer, Thyroid, PD-1.
What interventions are being tested in trial NCT04615988?
The interventions under investigation include: blood draw and questionnaire completion (OTHER), questionnaire completion, blood collection (OTHER).
Who is sponsoring clinical trial NCT04615988?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04615988 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04615988's enrollment target sits among peer trials
16 581st of 615 higher than 32 of 615 other Cancer trials
participants (enrollment target), bucketed by value
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