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NCT00316823 Clinical Trial

Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules

Head and Neck Cancer Clinical Trial

Official title:
Gene Expression Analysis in Thyroid Nodule FNA Samples

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00316823
Other study ID # CDR0000456480
Secondary ID UCSF-H28355-2702
Status Completed
Phase N/A
First received April 19, 2006
Last updated February 21, 2014
Start date July 2005

Study information
Verified date December 2008
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Genetic:
• gene expression analysis

• polymerase chain reaction

• reverse transcriptase-polymerase chain reaction

Other:
• diagnostic laboratory biomarker analysis

• immunohistochemistry staining method

Procedure:
• needle biopsy

Locations
Country Name City State
United States UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California

Sponsors (2)
Lead Sponsor Collaborator
University of California, San Francisco National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of biomarkers by mRNA expression analysis No
Primary Correlate levels of gene expression with the aggressiveness of differentiated thyroid cancer in FNA biopsy samples No
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