biostudies-literatureNiedzwiecki DCancer Research UKNCI NIH HHS3047-53https://www.ebi.ac.uk/biostudies/studies/S-EPMC5012711biostudies-literatureUnknown34(25)<h4>Purpose</h4>Conventional staging methods are inadequate to identify patients with stage II colon cancer (CC) who are at high risk of recurrence after surgery with curative intent. ColDx is a gene expression, microarray-based assay shown to be independently prognostic for recurrence-free interval (RFI) and overall survival in CC. The objective of this study was to further validate ColDx using formalin-fixed, paraffin-embedded specimens collected as part of the Alliance phase III trial, C9581.<h4>Patients and methods</h4>C9581 evaluated edrecolomab versus observation in patients with stage II CC and reported no survival benefit. Under an initial case-cohort sampling design, a randomly selected subcohort (RS) comprised 514 patients from 901 eligible patients with available tissue. Forty-nJournal of clinical oncology : official journal of the American Society of Clinical OncologyAssociation Between Results of a Gene Expression Signature Assay and Recurrence-Free Interval in Patients With Stage II Colon Cancer in Cancer and Leukemia Group B 9581 (Alliance).PMC5012711U10 CA180882P30 CA016058U10 CA180820U10 CA180850U10 CA180867U24 CA196171U10 CA180821U10 CA180888U10 CA077202U10 CA18083813721Colacchio TAMulligan JMJohnston PGGoldberg RMDavison TSO'Brien EKerr PWarren RSYe XMayer RJKennedy RDInnocenti FBertagnolli MMFrankel WLSchilsky RLNiedzwiecki DVenook APHarkin DPFriedman PNfalseAssociation Between Results of a Gene Expression Signature Assay and Recurrence-Free Interval in Patients With Stage II Colon Cancer in Cancer and Leukemia Group B 9581 (Alliance).<h4>Purpose</h4>Conventional staging methods are inadequate to identify patients with stage II colon cancer (CC) who are at high risk of recurrence after surgery with curative intent. ColDx is a gene expression, microarray-based assay shown to be independently prognostic for recurrence-free interval (RFI) and overall survival in CC. The objective of this study was to further validate ColDx using formalin-fixed, paraffin-embedded specimens collected as part of the Alliance phase III trial, C9581.<h4>Patients and methods</h4>C9581 evaluated edrecolomab versus observation in patients with stage II CC and reported no survival benefit. Under an initial case-cohort sampling design, a randomly selected subcohort (RS) comprised 514 patients from 901 eligible patients with available tissue. Forty-n2016-01-01T00:00:00Z2016 Sep2025-04-26T14:14:23.13Z2019-03-27T02:23:41ZS-EPMC50127112743292410.1200/JCO.2015.65.469910.1200/jco.2015.65.4699