Clinical trial · Observational
Correlation Vitamin D Level to Endocrine Autoimmune Toxicity Due to Immune Checkpoint Inhibitors
Correlation of Serum Vitamin D Level With the Development of Endocrine Autoimmune Complications During Treatment With Immune Checkpoint Inhibitors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| PD-1 | — | UNRESOLVED | — |
| Thyroid | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood draw and questionnaire completion | Other | — | UNRESOLVED |
| questionnaire completion, blood collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants being treated with immunotherapy
- description
- Participants who are to receive standard of care immunotherapy targeting PD-1 or PDL1 as treatment for malignancy
- interventionNames
- Other: blood draw and questionnaire completion
- Other: questionnaire completion, blood collection
Primary outcomes (1)
- measure
- Number of participants with risk of developing autoimmune thyroid disease treated with single agent.
- timeFrame
- 20 weeks
- description
- 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
Secondary outcomes (6)
- measure
- Number of participants with risk of developing autoimmune thyroid disease treated with two agents.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available