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Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: April 19, 2006
Last updated: February 21, 2014
Last verified: December 2008

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 Intervention
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 Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Gene Expression Analysis in Thyroid Nodule FNA Samples

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Diagnostic accuracy of biomarkers by mRNA expression analysis
  • Correlate levels of gene expression with the aggressiveness of differentiated thyroid cancer in FNA biopsy samples

Estimated Enrollment: 400
Study Start Date: July 2005
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of a thyroid nodule that requires fine-needle aspiration biopsy or thyroidectomy to exclude a diagnosis of thyroid cancer


  • Platelet count ≥ 70,000/mm^3
  • PT (INR) ≤ 14.5
  • PTT ≤ 35.2
  • Not pregnant


  • No aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) 7 days before sample procurement
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00316823

United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Principal Investigator: Electron Kebebew, MD University of California, San Francisco
  More Information Identifier: NCT00316823     History of Changes
Other Study ID Numbers: CDR0000456480
Study First Received: April 19, 2006
Last Updated: February 21, 2014

Keywords provided by National Cancer Institute (NCI):
thyroid cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Thyroid Nodule
Neoplasms by Site
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Thyroid Diseases processed this record on September 20, 2017