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Thyroid Autoimmune Dysfunction Due to Immune Checkpoint Inhibitors

Overview

About this study

The primary objective is to characterize the immune cell phenotypes in thyroid fine needle aspirates (FNA) and the peripheral blood of patients with ICI-induced thyroid dysfunction using flow cytometry. Control patients will be those with thyroid nodules as well as autoimmune thyroid disease, with and without exposure to ICI.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Provide voluntary and written informed consent to be included in the study (for those who are not fluent in English, we will consult an interpreter who can go over the consent with patient).
  • ICI cohort patients: About to start ICI therapy or are currently on ICI therapy (patients who have started therapy, must have baseline thyroid function test values available for review) for treatment of their malignancy.
  • Non-ICI cohort patients: Referred to thyroid clinic for further evaluation of thyroid nodules, autoimmune thyroid disease and/or diagnosis of primary thyroid malignancy.
  • Must be willing to undergo blood collections as outlined in the protocol.
  • Patients who are already on thyroid replacement therapy are eligible only if they have had a ≥50% increase or decrease in dose in their thyroid replacement therapy since starting an ICI agent.

Exclusion Criteria:

  • Pregnant
  • Prisoners
  • Not willing to voluntarily consent or if withdraw consent at any time during the course or of the study.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mabel Ryder, M.D.

Closed for enrollment

Contact information:

Anupam Kotwal M.B.B.S.

(507) 266-0500

Kotwal.Anupam@mayo.edu

More information

Publications

Publications are currently not available

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CLS-20396294

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