The purpose of this study is to develop a standard reference set of specimens for use by investigators participating in the National Cancer Institutes Early Detection Research Network (EDRN) in defining false positive rates for new cancer biomarkers in women.
50 pre- and 50 post-menopausal healthy women who have no personal nor any strong family history of cancer will be recruited through the Research Blood Components and have between 225 -250 ml of blood drawn yielding sufficient sera for 350 0.3mL aliquots on each individual subject plus sufficient residual sera which will be pooled to construct 350 sets of 8 replicate serum specimens. At the same time, pooled sets of ovarian cancer cases stratified by menopausal status and histologic type will also be created providing 4 sets of 250 0.3ml aliquots from case recruited through an existing IRB protocol (Preoperative Predictors of Findings at Pelvic Surgery #2000p001678). Ca-125, CEA, and Ca 15-3 will be measured as standard markers in all subjects including the individual cases and controls as well as in the set of pooled specimens. The reference sets will be assembled and stored in barcoded capillary tubes in liquid nitrogen. Investigators requesting specimens to evaluate a new marker would receive a “blinded” test control panel of 200 individual controls, 8(replicate) pooled control specimens (to yield a co-efficient of variation on the assay), and a set of 4 pooled case specimens. Investigator would report the results of their assay to the EDRN data coordinating center which would provide statistical output including the means and standard errors for the marker in all controls and the pre-and post-menopausal groups, the coefficient of variation for the marker, estimates of the marker in the pooled specimens in relation to the control distribution, and performance relative to standard markers. Markers, whose levels in the case pools are more extreme than the best standard marker relative to the distribution in controls, would be promising candidates to move to the next level of validation.
There are currently no biomarkers annotated for this protocol.
No datasets are currently associated with this protocol.