Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules
|ClinicalTrials.gov Identifier: NCT00316823|
Recruitment Status : Completed
First Posted : April 21, 2006
Last Update Posted : February 24, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Masking:||None (Open Label)|
|Official Title:||Gene Expression Analysis in Thyroid Nodule FNA Samples|
|Study Start Date :||July 2005|
|Primary Completion Date :||December 2009|
- Diagnostic accuracy of biomarkers by mRNA expression analysis
- Correlate levels of gene expression with the aggressiveness of differentiated thyroid cancer in FNA biopsy samples
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|