Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules

Gene Expression Analysis in Thyroid Nodule FNA Samples

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00316823

Enrollment

400

Registered

2006-04-21

Start date

2005-07-31

Completion date

Unknown

Last updated

2014-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

thyroid cancer

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.

Interventions

GENETICgene expression analysis

GENETICpolymerase chain reaction

GENETICreverse transcriptase-polymerase chain reaction

OTHERdiagnostic laboratory biomarker analysis

OTHERimmunohistochemistry staining method

PROCEDUREneedle biopsy

Study design

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026