Molecular Markers in the Diagnostic and Prognostic Evaluation of Thyroid Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- OHSU Knight Cancer Institute
- Enrollment
- 847
- Locations
- 1
- Primary Endpoint
- The primary outcome is histologic lesion (benign (Graves, Hashimoto's, follicular adenoma or subtype of malignant lesion).
Study Overview
Brief Summary
The purpose of this study is to evaluate how common gene mutations are in benign and malignant thyroid lesions.
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:
Retrospective review of archived surgical pathology specimens at Oregon Health & Science University (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.
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(TNM Classification of Malignant Tumours)) 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Year to — (Child, Adult, Older Adult)
- Sex
- All
- 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
Outcomes
Primary Outcomes
The primary outcome is histologic lesion (benign (Graves, Hashimoto's, follicular adenoma or subtype of malignant lesion).
Time Frame: 7 years
Secondary Outcomes
- 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(7 years)