Molecular Markers in Thyroid Cancer
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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: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Molecular Markers in the Diagnostic and Prognostic Evaluation of Thyroid Cancer |
- 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 ]
- 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 ]
| Enrollment: | 847 |
| Study Start Date: | February 2007 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Biopsy |
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 |
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| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: | Kathryn G. Schuff, M.D. | Oregon Health and Science University |
More Information
No publications provided
| Responsible Party: | OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00598364 History of Changes |
| Other Study ID Numbers: | OHSUeIRB2844 |
| Study First Received: | January 10, 2008 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by OHSU Knight Cancer Institute:
|
thyroid nodule genetic mutation malignancy |
Additional relevant MeSH terms:
|
Thyroid Neoplasms Thyroid Diseases Endocrine Gland Neoplasms Neoplasms by Site |
Neoplasms Head and Neck Neoplasms Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013