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.
The National Cancer Institute's Division of Cancer Prevention has released a new funding opportunity to solicit organ-specific applications for Biomarker Developmental Laboratories (BDLs), one of the four scientific units of the recently funded Early Detection Research Network (EDRN). The EDRN is a national infrastructure funded to discover, develop, and validate biomarkers for risk assessment, detection, and molecular diagnosis and prognosis of early cancer. BDLs are responsible for the discovery, development, characterization, and testing of new, or the refinement of existing, biomarkers and biomarker assays for risk assessment, detection, and molecular diagnosis and prognosis of cancers.
The existing BDLs are primarily focused on ovary and gastrointestinal cancers. The proposed BDLs (to be supported under this funding opportunity) should be focused on one or more of the following cancers: breast, prostate and other genitourinary organs, or lung. In addition, cancers with rapidly rising incidence rates, e.g., endometrial, hepatocellular, kidney, thyroid, oropharyngeal cancers, and/or cancers with unique etiology, e.g., mesothelioma, will be considered.
The newly funded units of the Early Detection Research Network will be announced later in April. Successful applicants have already been notified. Those researchers who were not successful during the last round of applications are encouraged to apply to this opportunity.