ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
TSH Receptor Antibody Heterogeneity in Children and Adolescents With Graves' Disease

This study is currently recruiting participants.
Verified by Children's Hospital Boston, December 2007

Sponsored by: Children's Hospital Boston
Information provided by: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00335062
  Purpose

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medication often required for sustained immunological remission and the high risk of relapse when medication is withdrawn.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


Condition Phase
Graves' Disease
Phase I

ChemIDplus related topics:   Thyroid   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   TSH Receptor Antibody Heterogeneity in Children and Adolescents With Graves' Disease

Further study details as provided by Children's Hospital Boston:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

whole blood, serum, white cells.


Estimated Enrollment:   100
Study Start Date:   August 2005
Estimated Study Completion Date:   June 2008

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   2 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

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


Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335062

Contacts
Contact: Jessica R Smith, MD     617-919-2128     Jessica.smith@childrens.harvard.edu    
Contact: Rosalind S. Brown, MD     617-919-2866     Rosalind.brown@childrens.harvard.edu    

Locations
United States, Massachusetts
Childrens' Hospital Boston     Recruiting
      Boston, Massachusetts, United States, 02115
      Contact: Jessica R Smith, MD     617-919-2128     Jessica.smith@childrens.harvard.edu    
      Contact: Rosalind S Brown, MD     617-919-2866     Rosalind.brown@childrens.harvard.edu    
      Principal Investigator: Jessica R Smith, MD            
      Principal Investigator: Rosalind S Brown, MD            

Sponsors and Collaborators
Children's Hospital Boston

Investigators
Principal Investigator:     Rosalind S Brown     Children's Hosptial Boston/Harvard Medical School    
  More Information


THYROID DISEASE MANAGER © offers an up-to-date analysis of thyrotoxicosis, hypothyroidism, thyroid nodules and cancer, thyroiditis, and all aspects of human thyroid disease.  This link exits the ClinicalTrials.gov site
 
Keeps people up-to-date about new research findings, ongoing clinical research projects, new thyroid books, and other patient and physician thyroid organizations.  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Children's Hospital Boston ( Dr. Rosalind Brown )
Study ID Numbers:   S05-05-066
First Received:   June 6, 2006
Last Updated:   December 26, 2007
ClinicalTrials.gov Identifier:   NCT00335062
Health Authority:   United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Autoimmune thyroid disease  
Children and Adolescents  
TSH Receptor Antibodies  

Study placed in the following topic categories:
Antibodies
Goiter
Autoimmune Diseases
Eye Diseases
Graves Disease
Endocrine System Diseases
Endocrinopathy
Orbital Diseases
Graves' disease
Hyperthyroidism
Thyroid Diseases

Additional relevant MeSH terms:
Immune System Diseases
Exophthalmos

ClinicalTrials.gov processed this record on October 14, 2008




Links to all studies - primarily for crawlers