Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules
RATIONALE: Finding genetic markers for thyroid cancer in a biopsy specimen may help doctors diagnose thyroid cancer.
PURPOSE: This clinical trial is studying how well genetic analysis works in diagnosing thyroid cancer in patients with thyroid nodules.
Head and Neck Cancer
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Genetic: reverse transcriptase-polymerase chain reaction
Other: diagnostic laboratory biomarker analysis
Other: immunohistochemistry staining method
Procedure: needle biopsy
|Study Design:||Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Gene Expression Analysis in Thyroid Nodule FNA Samples|
- Diagnostic accuracy of biomarkers by mRNA expression analysis [ Designated as safety issue: No ]
- Correlate levels of gene expression with the aggressiveness of differentiated thyroid cancer in FNA biopsy samples [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
- Evaluate the diagnostic accuracy of biomarkers and mRNA expression analysis using fine-needle aspiration (FNA) biopsy samples from patients with thyroid nodules.
- Correlate the level of gene expression with the aggressiveness of differentiated thyroid cancer in FNA biopsy samples.
OUTLINE: Patients undergo fine-needle aspiration (FNA) biopsy as part of routine care. Additional thyroid tissue is collected during the biopsy for gene expression analysis. Patients who have already had a biopsy undergo FNA biopsy during thyroidectomy.
Tissue samples will be examined for gene expression by reverse transcriptase-polymerase chain reaction (PCR), real-time quantitative PCR, and immunohistochemistry.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316823
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Electron Kebebew, MD||University of California, San Francisco|