Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norman Eberhardt, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01433809
First received: September 12, 2011
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


Condition
Cancer of the Thyroid
Neoplasms, Thyroid
Thyroid Adenoma
Thyroid Cancer
Thyroid Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers in Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Enrollment: 1
Study Start Date: June 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433809

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Norman Eberhardt
Investigators
Principal Investigator: Norman Eberhardt, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Norman Eberhardt, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01433809     History of Changes
Other Study ID Numbers: 11-002846
Study First Received: September 12, 2011
Last Updated: January 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
thyroid cancer
thyroid neoplasm
thyroid adenoma

Additional relevant MeSH terms:
Adenoma
Neoplasms
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 23, 2014