The Boston Clinical Epidemiology Center (CEC) seeks continued participation in the Early Detection Research Network (EDRN) now as the Partners-Southwestern Clinical Epidemiology and Validation Center. The mission of our joint center is to streamline the movement of the most informative biomarkers for ovarian (and other female) cancers into clinical practice by assembling and disbursing clinical resources appropriate for the level of validation and by developing collaborative projects using our collective expertise in epidemiology, clinical oncology, biostatistics, and clinical biochemistry. Three premises will drive the day-to-day working of our center and improve responsiveness to EDRN needs. Premise one is that some existing paradigms related to screening need revision. The concept that """"""""risk,"""""""" """"""""early detection,"""""""" and """"""""prognostic"""""""" biomarkers are distinct is too narrow. Auto-antibodies to cancer antigens may be examples of biomarkers that overlap all three categories and whose development may offer a uniquely broad approach to disease control. The concept of """"""""one cancer, one biomarker"""""""" also needs to be re-thought. Histologjc subtypes of cancer may require multiple markers for detection;and a multiple marker panel would also increase the efficiency of screening for multiple cancers simultaneously. For this to occur, statistical techniques to combine information from multiple assays will need to be refined concurrent with technical developments for efficient testing of multiple analytes. Premise two is that familiar antibody-based assays will continue to be the standard in clinical labs for many years to come. Our CEC now includes a key investigator with decades of experience in creating, refining, and validating new assays for biomarkers, who will interact early with investigators and industrial partners to create assays that meet clinical laboratory standards and are ready for further validation in the broader EDRN network. Premise three is that CECs must take a more active role in moving markers forward into clinical use. To advance this goal, an important step would be the development of specimen sets addressing each level of validation, beginning with a """"""""standard reference set"""""""" composed of multiple identical sets of aliquots. These sets could fill a critical need for """"""""filtering"""""""" the large number of biomarkers being proposed for detection of ovarian (or other female) cancers in a manner that leads to a powerful database for comparing their performance. Promising biomarkers would be further evaluated using other cross-sectional and longitudinally collected specimens. Because the shortest route to regulatory approval for a new marker for ovarian cancer may be through indications other than general population screening, specimens sets will also be constructed that can address indications such as distinguishing benign from malignant pelvic masses, screening women at genetically high-risk, and prediction of recurrence. To conclude, strengths of the Partners-Southwestern Clinical Epidemiology and Validation Center are: a track record of participation in joint EDRN activities, the combined expertise of its investigators in epidemiology, clinical oncology, biostatistics, and clinical biochemistry;complementary grant support and industry relationships;and a comprehensive plan together with extensive and diverse clinical resources to move early detection biomarkers for ovarian and other women's cancers more rapidly forward into clinical use.
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