跳至主要内容
临床试验/NCT01433809
NCT01433809已完成不适用

Biomarkers in Thyroid Cancer

Norman Eberhardt1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
1
主要终点
Distinguish follicular adenoma from follicular carcinoma

研究概览

简要总结

This protocol will evaluate microRNA biomarkers in blood and fine-needle aspirate biopsies (FNAB) of thyroid nodules. MicroRNA profiles will be determined and evaluated for their utility in pre-operative diagnosis, in particular to distinguish benign from malignant throid neoplasms. Post-surgical fresh-frozen thyroid cancer tissue will be assessed for somatic mutations, mRNA, and microRNA expression patterns. FFPE tissue will be used to obtain H&E and unstained slides to specific biomarker results using immunohistochemistry.

详细描述

This protocol requires the collection of blood (5 ml), fine-needle aspirate biopsies (FNAB), and post-surgical thyroid cancer tissue. The post surgical tissue includes fresh-frozen tissue that is considered waste and in excess of that required for pathologic diagnosis, and archived formalin-fixed, paraffin-embedded tissue (FFPE). The blood will be used as a substrate for assessing known markers, including microRNA expression patterns that may be useful to predict disease and thyroid cancer morphotype. The FNABs will be used to screen the potential of markers for pre-operative diagnosis. The post-surgical fresh-frozen thyroid cancer tissue will be used to isolate DNA and RNA in order to assess somatic mutations (RAS and PAX8/PPAR-gamma rearrangement) and messenger RNA, and microRNA expression patterns. The FFPE tissue will be used to obtain H&E and unstained slides to validate results using immunohistochemistry. The goal of these studies is to define molecular markers that will accurately distinguish benign from malignant disease and the multiple thyroid cancer phenotypes. Current methods of distinguishing benign from malignant disease requires a detailed post-surgical analysis and no known markers have yet been identified to reliably differentiate the multiple thyroid cancer morphotypes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with palpable thyroid nodule suspicious for thyroid neoplasm
  • Patient selected to undergo fine needle biopsy for cytologic diagnosis
  • Male (18 years of age or older)
  • Female (18 years of age or older)

排除标准

  • 未提供

结局指标

主要结局

Distinguish follicular adenoma from follicular carcinoma

时间窗: 3 years

Biomarkers will be identified to distinguish benign follicular adenoma from follicular carcinoma of the thyroid.

次要结局

未报告次要终点

研究者

发起方
Norman Eberhardt
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Norman Eberhardt

MD

Mayo Clinic

研究点 (1)

Loading locations...

相似试验