Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00316823
First received: April 19, 2006
Last updated: February 21, 2014
Last verified: December 2008
  Purpose

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: 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 [ 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 ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316823

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Electron Kebebew, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00316823     History of Changes
Other Study ID Numbers: CDR0000456480, UCSF-H28355-27029-01, UCSF-05205
Study First Received: April 19, 2006
Last Updated: February 21, 2014
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Thyroid Neoplasms
Head and Neck Neoplasms
Thyroid Diseases
Thyroid Nodule
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014