Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm

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Brief Title

Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm

Official Title

Biomarkers in Thyroid Cancer

Brief Summary

      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.

Detailed Description

      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.

Study Type


Primary Outcome

Distinguish follicular adenoma from follicular carcinoma


Cancer of the Thyroid


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment


Start Date

June 2011

Completion Date

May 2013

Primary Completion Date

May 2013

Eligibility Criteria

        Inclusion Criteria:

          -  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)




18 Years - 90 Years

Accepts Healthy Volunteers



Norman Eberhardt, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Norman Eberhardt

Study Sponsor

Norman Eberhardt, PhD, Principal Investigator, Mayo Clinic

Verification Date

January 2014