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Submitted on August 10, 2005
Accepted on October 26, 2005
Division of Endocrinology and Metabolism, Department of Medicine (S.H., M.E., D. L., D.S.C., P.W.L, M.X.), Department of Otolaryngology-Head and Neck Surgery (R.P.T., M. B., A.L.C., D.S.), Department of Surgery (A.P.T.), the Johns Hopkins University School of Medicine, Baltimore, Maryland 21287; Division of Endocrinology and Metabolism (S.B.), the Johns Hopkins Bayview Medical Center, Baltimore, Maryland 21224; Division of Endocrinology and Metabolism (D.S.C.), Sinai Hospital of Baltimore, Maryland 21215
* To whom correspondence should be addressed. E-mail: mxing1{at}jhmi.edu.
Context Serum DNA methylation markers may potentially be useful in diagnosing thyroid cancer and monitoring its recurrence
Objective To assess the utility of serum DNA methylation as 1) a diagnostic test for patients with thyroid nodules, and 2) a monitoring test to detect thyroid cancer recurrence in previously treated patients.
Design, Setting, and Subjects Using real-time quantitative methylation-specific PCR, we analyzed the methylation status of five genes (CALCA, CDH1, TIMP3, DAPK and RAR
2) on 96 bisulfite-treated serum DNA samples isolated either preoperatively from solid thyroid nodule patients or from patients in follow-up for history of treated thyroid cancer.
Main Outcome Measure Diagnostic sensitivity, specificity, and accuracy of serum DNA methylation marker for thyroid cancer.
Results For the patients with thyroid nodules, when a positive result was defined by a serum methylation level above the appropriately chosen cut-off value for any one of the five genes, the preoperative diagnostic sensitivity for thyroid cancer was 68% (26/38), the specificity was 95% (18/19), and the overall preoperative diagnostic accuracy was 77%, with positive and negative predictive values of 96% and 60%, respectively. In a subset of patients with cytologically indeterminate thyroid nodules, serum DNA methylation testing could correctly diagnose 8/11 (73%) cancers and 4/4 (100%) benign tumors, with a diagnostic accuracy of 80%. We also analyzed these serum DNA methylation markers in 39 previously treated thyroid cancer patients. Among the 10 patients proved to have recurrent disease by conventional measures, seven (70%) were positive on methylation testing. Among the 29 patients who had no corroboration of residual or recurrent disease by conventional studies, six (21%) were positive for serum DNA methylation markers.
Conclusions We have demonstrated the potential usefulness of serum DNA methylation markers as a novel tool for differential diagnosis of solid thyroid nodules and thyroid cancer recurrence monitoring.
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