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Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00316823
First received: April 19, 2006
Last updated: February 6, 2009
Last verified: December 2008
History of Changes

April 19, 2006
February 6, 2009
July 2005
December 2009   (final data collection date for primary outcome measure)
  • 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 ]
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Complete list of historical versions of study NCT00316823 on ClinicalTrials.gov Archive Site
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Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules
Gene Expression Analysis in Thyroid Nodule FNA Samples

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.

OBJECTIVES:

  • 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.
Interventional
Not Provided
Masking: Open Label
Primary Purpose: Diagnostic
Head and Neck Cancer
  • Genetic: gene expression analysis
  • Genetic: polymerase chain reaction
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
  • Procedure: needle biopsy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
Not Provided
December 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

  • No aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) 7 days before sample procurement
Both
18 Years and older
No
Not Provided
United States
 
NCT00316823
CDR0000456480, UCSF-H28355-27029-01, UCSF-05205
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University of California, San Francisco
National Cancer Institute (NCI)
Principal Investigator: Electron Kebebew, MD University of California, San Francisco
National Cancer Institute (NCI)
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP