Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules

NCT ID: NCT00316823

Last Updated: 2014-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head and Neck Cancer

Study Design

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Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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gene expression analysis

Intervention Type GENETIC

polymerase chain reaction

Intervention Type GENETIC

reverse transcriptase-polymerase chain reaction

Intervention Type GENETIC

diagnostic laboratory biomarker analysis

Intervention Type OTHER

immunohistochemistry staining method

Intervention Type OTHER

needle biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Principal Investigators

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Electron Kebebew, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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UCSF-H28355-27029-01

Identifier Type: -

Identifier Source: secondary_id

UCSF-05205

Identifier Type: -

Identifier Source: secondary_id

CDR0000456480

Identifier Type: -

Identifier Source: org_study_id

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