A Study of New Laboratory Assays to Develop Better Therapies for Treating Patients with Graves’ Disease

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-007778
    Sponsor Protocol Number: 17-007778

About this study

This study is being done to see if better therapies can be developed to treat Graves’ disease, using new laboratory assays

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

STUDY IS CLOSED FOR ENROLLMENT

Inclusion Criteria:

Graves’ disease (GD) cohort 1

  • ≥18 years of age
  • TSH < 0.1 mIU/L
  • RAI scan and uptake: symmetric bilateral and> LLN%
  • Total T4 > 11.7 mcg/dL or total T3 > 200 ng/dL or Free T4 level: ≥1.7 ng/dL
  • Newly diagnosed Graves’ disease OR previously diagnosed Graves’ disease with recurrent disease, and has been off anti-thyroid medication for at least 3 months

Painless thyroiditis (PT) cohort 2

  • ≥18 years of age
  • TSH < 0.1 mIU/L
  • Thyroid uptake < 3%
  • Total T4 > 11.7 mcg/dL or total T3 > 200 ng/dL or Free T4 level: ≥1.7 ng/dL

Subacute thyroiditis (SA) cohort 3

  • ≥18 years of age
  • TSH < 0.1 mIU/L
  • Thyroid uptake < 3%
  • Total T4 > 11.7 mcg/dL, or total T3 > 200 ng/dL, or Free T4 level: ≥1.7 ng/dL
  • Presence of neck pain or Elevated ESR > ULN for age

Hashimoto’s thyroiditis with hypothyroidism (HT) cohort 4

  • ≥18 years of age
  • TSH > 4.2 mIU/L (normal TSH acceptable if patient is already on levothyroxine)
  • TPO antibodies >9 IU/L or ULN for the assay used or US pattern, cytology or pathology consistent with HT
  • History of RAI therapy or external radiation to thyroid;
  • History of thyroid cancer

Graves’ orbitopathy (GO) cohort 5

  • ≥18 years of age
  • Presence of eye manifestations for GO; active (CAS≥3)
  • History of autoimmune thyroid disease

Euthyroid Graves’ orbitopathy (EGO) cohort 6

  • Same as GO – this is basically a subgroup of GO that is euthyroid (preferred those that have never been hyper- or hypothyroid)
  • Normal TSH cascade

Healthy volunteers cohort 7

  • Normal TSH

Inactive Graves’ Orbitopathy (IGO) cohort 8

  • ≥18 years of age
  • Presence of eye manifestations for GO with inactive disease (CAS<3)
  • History of autoimmune thyroid disease

Exclusion Criteria:

Graves’ disease (GD) cohort 1

  • Prior treatment with thyroidectomy or radioiodine or concurrent treatment with anti-thyroid drugs.
  • Subjects with Graves’ orbitopathy

Painless thyroiditis (PT) cohort 2

  • Exposure to iodinated contrast within 4 weeks
  • Neck pain

Subacute thyroiditis (SA) cohort 3

  • Exposure to iodinated contrast within 4 weeks

Hashimoto’s thyroiditis with hypothyroidism (HT) cohort 4

  • History of RAI therapy or external radiation to thyroid;
  • History of thyroid cancer

Graves’ orbitopathy (GO) cohort 5

  • History of radiation to orbits
  • Immunomodulatory therapy (exception: patients that received oral steroids more than 4 weeks prior to enrollment are allowed in the study).
  • Orbital surgery

Euthyroid Graves’ orbitopathy (EGO) cohort 6

  • History of radiation to orbits;
  • Immunomodulatory therapy (exception: patients that received oral steroids more than 4 weeks prior to enrollment are allowed in the study).
  • Orbital surgery
  • Prior therapy with thyroidectomy, radioactive iodine or anti-thyroid drugs

Healthy volunteers cohort 7

  • Personal history of thyroid disease
  • Use of medications known to affect thyroid function
  • FNA of thyroid nodule results other than benign
  • Current or prior use of thyroid hormone replacement

Inactive Graves’ Orbitopathy (IGO) cohort 8

  • History of radiation to orbits
  • Immunomodulatory therapy (exception: patients that received oral steroids more than 4 weeks prior to enrollment are allowed in the study).
  • Orbital surgery

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Marius Stan, M.D.

Open for enrollment

Contact information:

Brandon Messmer

(507)538-8472

Messmer.Brandon@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20368637

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