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Molecular Markers in Thyroid Cancer
This study is currently recruiting participants.
Verified by Oregon Health and Science University, January 2009
First Received: January 10, 2008   Last Updated: February 4, 2009   History of Changes
Sponsor: Oregon Health and Science University
Information provided by: Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00598364
  Purpose

The purpose of this study is to evaluate how common gene mutations are in benign and malignant thyroid lesions.


Condition Intervention
Thyroid Cancer
Other: fine needle aspiration biopsy

Study Type: Interventional
Study Design: Diagnostic, Open Label, Single Group Assignment
Official Title: Molecular Markers in the Diagnostic and Prognostic Evaluation of Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • The primary outcome is histologic lesion (benign (Graves, Hashimoto's, follicular adenoma or subtype of malignant lesion). [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The main secondary outcome to be measured in malignant lesions includes measures of biologic behavior of malignant lesions including capsular and angiolymphatic invasion, local invasion and lymph node metastases at presentation [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: February 2007
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: fine needle aspiration biopsy
    Prospective evaluation of thyroid cytologic specimens obtained at the time of the fine needle aspiration (FNA) biopsy which is done as standard of care in the evaluation of thyroid nodules and goiters and peripheral blood samples at the time of biopsy, surgery or standard of care clinical evaluation in OHSU patients. Molecular markers will be evaluated on preoperative cytologic material and peripheral blood samples and compared with postoperative evaluation of molecular markers on surgical specimens from the OHSU Cancer Institute Tissue Bank.
Detailed Description:

The overall objective of this study is to evaluate the prevalence of molecular markers in patients with benign and malignant thyroid lesions. This study consists of two parts:

Part One: Retrospective review of archived surgical pathology specimens at OHSU from patients with thyroid cancer or benign thyroid disease (nodules or goiter) who underwent thyroidectomy and/or neck dissection as standard of care. Molecular markers will be evaluated on archived tissue.

Part Two: Prospective evaluation of thyroid cytologic specimens obtained at the time of the fine needle aspiration biopsy which is done as standard of care in the evaluation of thyroid nodules and goiters and peripheral blood samples at the time of biopsy or surgery in OHSU patients. Molecular markers will be evaluated on preoperative cytologic material and peripheral blood samples and compared with postoperative evaluation of molecular markers on surgical specimens from the OHSU Cancer Institute Tissue Bank.

In both parts, molecular markers will be correlated with clinical information extracted from OHSU medical records: histologic subtype of cancer, measures of tumor aggressiveness (capsular and angiolymphatic invasion, local invasion, lymph node and distant metastases, TNM stage) and clinical outcome (recurrence, distant metastases and death).

Patients with other malignancies presenting for standard of care services will have peripheral blood collected for DNA, RNA and buffy coat/white blood cells as a "positive" control for the DNA/RNA isolation techniques and mutation assays, as other cancers commonly express some of the same mutations. Normals will have peripheral blood collected for DNA, RNA and buffy coat/white blood cells as a "negative" control for the DNA/RNA isolation techniques and mutation assays.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 1 - 100
  • Benign or malignant thyroid lesion, other malignancy or no thyroid abnormality
  • Pathologic specimen available for analysis
  • Ability to provide informed consent (for prospective study, Part Two)
  • Age greater than age 18 (for normal controls)

Exclusion Criteria:

  • Patients without adequate data for analysis
  • Histopathologic or cytopathologic diagnosis of for medullary thyroid carcinoma (not derived from the thyroid follicular epithelium), thyroid lymphoma
  • Unwilling to participate or unable to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598364

Contacts
Contact: Erin F Neal, B.S. 503-346-0355 neale@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Kathryn G. Schuff, M.D.            
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Kathryn G. Schuff, M.D. Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Oregon Health & Science University ( Kathryn Schuff, M.D. )
Study ID Numbers: OHSUeIRB2844
Study First Received: January 10, 2008
Last Updated: February 4, 2009
ClinicalTrials.gov Identifier: NCT00598364     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
thyroid
nodule
genetic
mutation
malignancy

Additional relevant MeSH terms:
Thyroid Neoplasms
Neoplasms
Thyroid Diseases
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on February 04, 2010