The 12-gene colon cancer assay validation and utility: Summary of clinical evidence
Autor: | Mark A Lee, Haluk Tezcan, Margarita Lopatin, Kim M. Clark-Langone, Steven Shak, Amy P. Sing, Emily Burke |
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Rok vydání: | 2014 |
Předmět: | |
Zdroj: | Journal of Clinical Oncology. 32:523-523 |
ISSN: | 1527-7755 0732-183X |
Popis: | 523 Background: The 12-gene colon cancer assay is the first commercially available molecular assay to predict the risk of recurrence in stage II/III colon and rectal cancer. Rigorous evidence for clinical validity and utility of an assay is imperative since the result is used for treatment decision-making. This summary outlines the studies that meet an established definition of clinical validation and additional studies that support the utility of the assay. Methods: Prospectively designed studies using archival tissue with pre-specified methods, clinical outcomes, and analysis plan were considered clinical validation studies (Simon et al. JNCI 2009). Additional studies that demonstrated the utility of the assay in a clinical setting were considered supportive. Results: The assay has been clinically validated in four independent studies with 3315 patients (2390 stage II/628 stage III colon and 130 stage II/167 stage III rectal). All four studies demonstrated a significant association (p |
Databáze: | OpenAIRE |
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