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
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 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:
Head and Neck Neoplasms
Thyroid Nodule
Neoplasms by Site
Neoplasms
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on October 19, 2014