Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|