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The 50 published microarray studies were selected based on prognosis signature inclusion criteria.
This signature outperforms standard clinical and histological criteria in predicting the likelihood of distant metastases within five years [4].
For each signature size, a criterion designed to estimate the stability of a signature was computed, as recently introduced by Davis and colleagues [ 9].
As part of the trial, they received a disease recurrence risk estimate based on a 70-gene signature and on standard clinical criteria as scored via a modified version of Adjuvant!
If the threshold value is determined according to some criteria, the signature could be more robust although more time will be consumed.
We selected among probesets used in the LOOCV those four ones from each signature that fulfilled the criteria explained above.
HV were included in the study after interview at the CIC, verification of selection criteria and signature of consent.
Based on these two criteria, new signature gene set selection algorithm tailored for small samples were developed (see METHOD for details).
The MINDACT (Microarray In Node negative Disease may Avoid ChemoTherapy) multicentre clinical trial [ 11] is a prospective, randomised study that aims to compare the NKI 70-gene expression signature [ 3] with clinicalpathological criteria (Adjuvant! Online) commonly used in selecting patients for adjuvant chemotherapy in node-negative breast cancer (Table 1).
Quality control criteria selected a signature of 321 miRNAs worthy of downstream analysis.
These strict selection criteria for gene signature candidates, based on prior hypothesis, helped to reduce the risk of over-fitting during Cox regression analysis.
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