Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules

Study Overview
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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.

Official Title
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Gene Expression Analysis in Thyroid Nodule FNA Samples

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Genetic: gene expression analysis
* Genetic: polymerase chain reaction
* Genetic: reverse transcriptase-polymerase chain reaction
* Other: diagnostic laboratory biomarker analysis
* Other: immunohistochemistry staining method
* Procedure: needle biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Genetic: polymerase chain reaction|nan|
|Genetic: reverse transcriptase-polymerase chain reaction|nan|
|Other: diagnostic laboratory biomarker analysis|nan|
|Other: immunohistochemistry staining method|nan|
|Procedure: needle biopsy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of biomarkers by mRNA expression analysis |  |  | 
| Correlate levels of gene expression with the aggressiveness of differentiated thyroid cancer in FNA biopsy samples |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroid cancer