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Vitamin d levels may predict thyroid side effects in cancer treatment

NCT ID NCT04615988

Knowledge-focused Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether the amount of vitamin D in your blood affects your chance of developing thyroid problems while receiving immunotherapy for cancer. Researchers will measure vitamin D and thyroid function before and during standard cancer treatment. The goal is to see if people with low vitamin D are more likely to have thyroid side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 17 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Eligible subjects are adults age 18 or older with advanced cancer and are planned to receive standard of care treatment with a PD-1/L-1 inhibitor or with standard of care anti-CTLA-4 plus antiPD-1/L1 inhibitors.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cancer neoplasm thyroid gland disorder thyroid tumor vitamin D deficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer PD-1 Thyroid

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mount Sinai Hospital /Tisch Cancer Cancer/Ruttenberg Treatment Center

    RECRUITING

    New York, New York, 10029, United States

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