Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm

Thyroid Cancer Clinical Trial

Official title:

Biomarkers in Thyroid Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433809
• Other study ID #: 11-002846
• Status: Completed
• Phase: N/A
• First received: September 12, 2011
• Last updated: January 20, 2014
• Start date: June 2011
• Est. completion date: May 2013

Study information

• Verified date: January 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer of the Thyroid
• Neoplasms
• Neoplasms, Thyroid
• Thyroid Adenoma
• Thyroid Cancer
• Thyroid Carcinoma
• Thyroid Diseases
• Thyroid Neoplasms

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Norman Eberhardt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distinguish follicular adenoma from follicular carcinoma	Biomarkers will be identified to distinguish benign follicular adenoma from follicular carcinoma of the thyroid.	3 years	No