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
Rok vydání:	2014
Předmět:	Oncology medicine.medical_specialty Pathology Cancer Research Colorectal cancer business.industry Stage ii medicine.disease Clinical evidence Internal medicine Clinical validity medicine Archival tissue Stage (cooking) business
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
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8b6c05feafc1df1f13e906a2dfc90850 https://doi.org/10.1200/jco.2014.32.3_suppl.523 Zobrazit plný text záznamu