Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01433809
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : January 22, 2014
Information provided by (Responsible Party):
Norman Eberhardt, Mayo Clinic

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.

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

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
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers in Thyroid Cancer
Study Start Date : June 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid
U.S. FDA Resources

Primary Outcome Measures :
  1. Distinguish follicular adenoma from follicular carcinoma [ Time Frame: 3 years ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01433809

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

Responsible Party: Norman Eberhardt, MD, Mayo Clinic Identifier: NCT01433809     History of Changes
Other Study ID Numbers: 11-002846
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014

Keywords provided by Norman Eberhardt, Mayo Clinic:
thyroid cancer
thyroid neoplasm
thyroid adenoma

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