Clinical trial NCT01433809: Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm
Official title: Biomarkers in Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of the Thyroid
Neoplasms, Thyroid
Thyroid Adenoma
Thyroid Cancer
Thyroid Carcinoma
Keywords: thyroid cancer
thyroid neoplasm
thyroid adenoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-09-14
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals undergoing fine needle biopsy for diagnosis of thyroid cancer, who provide written consent to enter the study.

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.

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)

Primary outcomes:
measure: Distinguish follicular adenoma from follicular carcinoma
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Norman Eberhardt, PhD
role: PRINCIPAL_INVESTIGATOR
References: