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| 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 |
| 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) |
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:
Exclusion Criteria:
Contacts and Locations| Contact: Erin F Neal, B.S. | 503-346-0355 | neale@ohsu.edu |
| United States, Oregon | |
| Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: Kathryn G. Schuff, M.D. | |
| Principal Investigator: | Kathryn G. Schuff, M.D. | Oregon Health and Science University |
More Information
| 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 |
|
thyroid nodule genetic mutation malignancy |
|
Thyroid Neoplasms Neoplasms Thyroid Diseases Neoplasms by Site |
Head and Neck Neoplasms Endocrine System Diseases Endocrine Gland Neoplasms |