Gene Expression Analysis in Thyroid Nodule FNA Samples
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of biomarkers by mRNA expression analysis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Diagnostic accuracy of biomarkers by mRNA expression analysis
Correlate levels of gene expression with the aggressiveness of differentiated thyroid cancer in FNA biopsy samples
次要结局
未报告次要终点