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APHA Scientific Session and Event Listing

Steven James Skates, PhD, Biostatistics Center, Assistant Professor of Medicine (Biostatistics), Harvard Medical School, 50 Staniford Street, Massachusetts General Hospital, Suite 560, Boston, MA 02114, (617) 726-4309, SSkates@partners.org

Retrospective analyses of biomarker data from ovarian cancer screening trials indicates that information in longitudinal serum biomarker behavior enhances the sensitivity for early detection while maintaining the same high level of specificity achieved by a fixed cutoff. In the trials, regular blood samples are taken and a biomarker measured to identify subjects at risk for having ovarian cancer and therefore referred to ultrasound. To combine the information in biomarker levels at multiple time points, statistical models of longitudinal behavior are developed for subjects without ovarian cancer in the study, and for subjects who subsequently develop ovarian cancer following the blood draws. The longitudinal model for control subjects posits a stable distribution of the biomarker with an individual mean level, while for ovarian cancer cases it posits the same individual mean level, then an unknown change point followed by an exponentially increasing mean corresponding to an individual tumor doubling time. Prospective application of the longitudinal approach is then discussed.

Learning Objectives:

• At the conclusion of the session, the participant (learner) in this session will understand that use of longitudinal serum biomarker behavior may enhance the sensitivity for early detection of ovarian cancer.

Presenting author's disclosure statement:

Any relevant financial relationships? Yes

Organization	Clinical/Research Area	Type of Relationship
FDI	Cancer Biomarkers	Independent Contractor (contracted research and clinical trials)

Any company-sponsored training?	No
Any institutionally-contracted trials related to this submission?	Yes
Have you received salary support, retainer, or other monies to support your position as part of the research/clinical trials?	No
Have you served as the Principal Investigator) for the research/clinical trials?	Yes
Have the results of your research/clinical trials been published?	No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.