Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules
NCT ID: NCT00316823
Last Updated: 2014-02-24
Study Results
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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COMPLETED
NA
400 participants
INTERVENTIONAL
2005-07-31
Brief Summary
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PURPOSE: This clinical trial is studying how well genetic analysis works in diagnosing thyroid cancer in patients with thyroid nodules.
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Detailed Description
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* 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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Study Design
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DIAGNOSTIC
NONE
Interventions
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gene expression analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
diagnostic laboratory biomarker analysis
immunohistochemistry staining method
needle biopsy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of California, San Francisco
OTHER
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
Countries
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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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