Molecular Markers in Thyroid Cancer
|ClinicalTrials.gov Identifier: NCT00598364|
Recruitment Status : Completed
First Posted : January 21, 2008
Last Update Posted : December 8, 2014
|Condition or disease|
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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||847 participants|
|Target Follow-Up Duration:||13 Years|
|Official Title:||Molecular Markers in the Diagnostic and Prognostic Evaluation of Thyroid Cancer|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Thyroidectomy or neck dissection
Patients with thyroid cancer or benign thyroid disease (nodules or goiter) who underwent thyroidectomy and/or neck dissection as standard of care.
- The primary outcome is histologic lesion (benign (Graves, Hashimoto's, follicular adenoma or subtype of malignant lesion). [ Time Frame: 7 years ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598364
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Kathryn G. Schuff, M.D.||Oregon Health and Science University|