Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm
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.
Cancer of the Thyroid
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Biomarkers in Thyroid Cancer|
- Distinguish follicular adenoma from follicular carcinoma [ Time Frame: 3 years ] [ Designated as safety issue: No ]Biomarkers will be identified to distinguish benign follicular adenoma from follicular carcinoma of the thyroid.
Biospecimen Retention: Samples With DNA
Blood, RNA/DNA from fine needle aspirate biopsies of thyroid nodules, fresh frozen surgical tissue, formalin fixed paraffin embedded tissue.
|Study Start Date:||June 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433809
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Norman Eberhardt, PhD||Mayo Clinic|