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
Observational
Primary Outcome
Distinguish follicular adenoma from follicular carcinoma
Condition
Cancer of the Thyroid
Publications
* 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
1
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)
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Norman Eberhardt, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01433809
Organization ID
11-002846
Responsible Party
Sponsor-Investigator
Study Sponsor
Norman Eberhardt
Study Sponsor
Norman Eberhardt, PhD, Principal Investigator, Mayo Clinic
Verification Date
January 2014