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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Children's Hospital Boston.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00335062
First received: June 6, 2006
Last updated: January 27, 2009
Last verified: January 2009

June 6, 2006
January 27, 2009
August 2005
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Complete list of historical versions of study NCT00335062 on ClinicalTrials.gov Archive Site
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TSH Receptor Antibody Heterogeneity in Children and Adolescents With Graves' Disease
TSH Receptor Antibody Heterogeneity in Children and Adolescents With Graves' Disease

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medication often required for sustained immunological remission and the high risk of relapse when medication is withdrawn.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.

In the present grant proposal, we plan to utilize two new assays (binding and bioassay) in order to identify additional predictors of Graves' disease and apply them to a well characterized group of patients with Graves' disease followed prospectively. More specifically, we plan to further investigate the antibodies by measuring lambda: kappa light chain antibody ratios in pediatric patients. We will assess epitope heterogeneity by using novel chimeric proteins in which specific portions of the TSH receptor have been replaced with the closely related LH receptor. We will utilize microarray technology to determine if there are differences in gene expression profiles in responders versus non responders. It is hoped that these methods will lead to an improved ability to follow disease progression and to monitor efficacy of therapy.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

whole blood, serum, white cells.

Non-Probability Sample

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

Graves' Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2009
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Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Toxic Nodule
  • Currently receiving steroids or thyroid hormone replacement
  • Bacterial, Viral, Radiation, or Autoimmune thyroiditis
Both
2 Years to 21 Years
No
Contact: Rosalind S Brown, MD 617-919-2866 Rosalind.brown@childrens.harvard.edu
Contact: Andrea R. Hale, RN 617-919-2867 Andrea.Hale@childrens.harvard.edu
United States
 
NCT00335062
S05-05-066
Yes
Dr. Rosalind Brown, Children's Hospital Boston
Children's Hospital Boston
Not Provided
Principal Investigator: Rosalind S Brown Children's Hosptial Boston/Harvard Medical School
Children's Hospital Boston
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP