Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules - Full Text View

Sponsors and Collaborators:	UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00316823

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	Procedure: gene expression analysis Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: needle biopsy Procedure: polymerase chain reaction Procedure: reverse transcriptase-polymerase chain reaction

MedlinePlus related topics: Cancer Head and Neck Cancer Thyroid Cancer

Drug Information available for: Thyroid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	Gene Expression Analysis in Thyroid Nodule FNA Samples

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	Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222

Sponsors and Collaborators

UCSF Helen Diller Family Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Electron Kebebew, MD

UCSF Helen Diller Family Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000456480, UCSF-H28355-27029-01, UCSF-05205
Study First Received:	April 19, 2006
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00316823
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

thyroid cancer

Study placed in the following topic categories:

Thyroid Nodule
Thyroid Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

Endocrinopathy
Thyroid Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009