TSH Receptor Antibody Heterogeneity in Children and Adolescents With Graves' Disease

NCT00335062 | Completed DMC

• 1 other identifier: S05-05-066
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Graves' disease, the most common form of hyperthyroidism in children, is caused by Thyrotropin (TSH) Receptor Antibodies (TRAbs) that mimic the action of TSH. The disease leads to significant morbidity in children both due to the prolonged course of antithyroid medication often required for sustained immunological remission and the high risk of relapse when medication is withdrawn. The ability to predict which patients are most likely to fail medical management would greatly improve the choice of therapy. In the past, large goiter size, age at diagnosis, increased biochemical severity, and decreased body mass index have all been associated with a poorer prognosis, but these clinical indicators lack sensitivity and specificity. Preliminary data suggest that the new TRAb assays are both sensitive and specific for the measurement of TRAbs in children with Graves' disease. In addition, variation in these antibodies over time is not the same in all patients. The goal of this proposal will be to prospectively follow children with newly diagnosed Graves' disease and use microarray technology to determine if there are genes whose expression differ in patients who respond to medical therapy versus those who will need more definitive therapy earlier in their disease.

Conditions

Graves' Disease

Keywords

Autoimmune thyroid disease; Children and Adolescents; TSH Receptor Antibodies

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the disappearance of TSH receptor Abs (as assessed by both ELISA and bioassay) from the circulation.

  end of study

Secondary Outcomes (1)

• 2) The secondary outcome will be normalization of thyroid function tests (T4, free T4, Total T3, and TSH) on a low dose of Tapazole 2.5-5.0 mg per day.

  end of study

Other Outcomes (1)

• 3) In the neonatal Graves' disease patient, the primary outcome will be the clearance of both TBII and TSI from the infant's sera (as assessed by both ELISA and bioassay).

  end of study

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents referred to a tertiary medical center with hyperthyroidism.

You may qualify if:

• Age 2-21 years
• Suppressed Thyroid Stimulating Hormone (TSH)
• Elevated Triiodothyronine (T3), Thyroxine (T4)

You may not qualify if:

• Pregnancy
• Toxic Nodule
• Currently receiving steroids or thyroid hormone replacement
• Bacterial, Viral, Radiation, or Autoimmune thyroiditis

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Childrens' Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Links

• THYROID DISEASE MANAGER © offers an up-to-date analysis of thyrotoxicosis, hypothyroidism, thyroid nodules and cancer, thyroiditis, and all aspects of human thyroid disease.

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells.

MeSH Terms

Conditions

Graves Disease

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rosalind S Brown

  Children's Hosptial Boston/Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Trials

Study Record Dates

• First Submitted: June 6, 2006
• First Posted: June 8, 2006
• Study Start: August 1, 2005
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: July 25, 2014

Record last verified: 2014-07

Locations

US (1)