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Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
gene expression analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
diagnostic laboratory biomarker analysis
immunohistochemistry staining method
needle biopsy
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer focused on measuring thyroid cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Diagnostic accuracy of biomarkers by mRNA expression analysis
Correlate levels of gene expression with the aggressiveness of differentiated thyroid cancer in FNA biopsy samples

Secondary Outcome Measures

Full Information

First Posted
April 19, 2006
Last Updated
February 21, 2014
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00316823
Brief Title
Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules
Official Title
Gene Expression Analysis in Thyroid Nodule FNA Samples
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2009 (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
thyroid cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Type
Genetic
Intervention Name(s)
reverse transcriptase-polymerase chain reaction
Intervention Type
Other
Intervention Name(s)
diagnostic laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Procedure
Intervention Name(s)
needle biopsy
Primary Outcome Measure Information:
Title
Diagnostic accuracy of biomarkers by mRNA expression analysis
Title
Correlate levels of gene expression with the aggressiveness of differentiated thyroid cancer in FNA biopsy samples

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Electron Kebebew, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules

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