Grant: Partnerships for Health System Improvement (PHSI)

<html> <body>Cancer control and prevention is a global health priority, and cervical cancer (CC), although preventable, remains a leading cause of cancer for women. In this time of rapid evolution in the field of CC prevention programs, decision makers are faced with <strong>key knowledge gaps</strong> as they structure the future of this widely used screening program to ensure investments and efforts in screening programs are effective. Specifically, questions regarding <strong><em>which test(s) to use</em></strong> <strong>and</strong> <strong><em>how to use them</em></strong> <strong>to maximize cervical cancer prevention while minimizing health care impacts</strong> remain unanswered.<br> <br> <strong>Study Goals</strong> <br> Building on our global leadership and expertise, comprehensive research trial infrastructure and our national global policy and research team, this project will <em>determine the optimal approach to detection of</em> <em>cervical cancer</em> <em>in the setting of molecular based, HPV screening</em>. Specifically, using performance measures such as Sensitivity (Sn), Specificity (Sp), Negative Predictive Value (NPV), Positive Predictive Value (PPV), defined from stored specimens from the large CIHR funded FOCAL trial, and partnering with the Canadian Partnership Against Cancer (CPAC) Cancer Risk Management model (CRMM), we plan to:<br> <br> 1. Define the impact of different screening triage algorithms for HPV positive women ages 25-69 on CC rates; treatment rates; reproductive sequelae; health systems costs<br> 2. Determine the impact of alternate molecular tools as primary screening for CC <br> for CC in <strong>different vaccine uptake scenarios</strong> on health systems outcomes<br> <br> <strong>5. Study Objectives</strong> <br> <em>Individual level outcomes</em> <br> 1. Using bio-bank FOCAL specimens, determine <strong>performance</strong> of commercially available and in-development molecular assays as triage for HPV positive specimens (ie. Sn; Sp; PPV; NPV) for Cervical Intraepithelial Neoplasia 2 or greater (CIN2+) of five-year age strata including:<br> i. <strong>Roche Cobas HPV assay</strong> (type specific HPV-DNA)<br> ii. <strong>Gen-Probe APTIMA assay</strong> (HPV E6/E7 mRNA)<br> <strong>iii. DNA methylation</strong> <br> <em>2.</em> Using stored specimens, determine <strong>performance</strong> of these assays as a primary screen for CIN2+ using similar measures<br> <br> <em>Population level outcomes</em> <br> Through the CRMM, using parameters generated from this analysis:<br> 1. Determine <strong>impact</strong> of <em>screening algorithms</em> with different assays as triage for HPV positive women <strong><em>OR</em></strong> as a primary screen for CC on population level testing; colposcopy rates; reproductive sequelae; uptake of screening; treatment; harms; cervical cancer in <strong>different vaccine</strong> <strong>uptake scenarios</strong> <br> 2. Provide provincial partners with policy guidance on optimal screening protocols for their jurisdictions, based on study findings through mathematical modelling<br> <br> <strong>Project Outputs</strong> <br> <br> Findings from this research will create region specific algorithms through CRMM and offer <em>insights</em> to the best use of rapidly emerging CCS molecular technology and the HPV vaccine in a cost-effective manner. This research will enable us to provide partners with policy guidance on optimal CC screening protocols tailored for their regions. Screening algorithms will shape the care for millions of women and ultimately reduce CC in Canada and globally. <br> <br> The research team is uniquely poised globally to address these critical knowledge gaps and lead this practice changing research for the future of CCS. Critical policy partners include Canadian Partnership Against Cancer; BC Cancer Agency; Cancer Care Ontario; Canadian Task Force on Preventive Health Care; US Preventive Services Task Force; World Health Organization</body> </html>