Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm
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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 |
- 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.
| Estimated Enrollment: | 1000 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | September 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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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)
Contacts and Locations
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 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
thyroid cancer thyroid neoplasm thyroid adenoma |
Additional relevant MeSH terms:
|
Adenoma Neoplasms Carcinoma Thyroid Neoplasms Thyroid Diseases Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Endocrine Gland Neoplasms Neoplasms by Site Head and Neck Neoplasms Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013