For the past two decades, despite the availability of highly sensitive screening approaches such as human papillomavirus (HPV) testing, over 13,000 women continue to be diagnosed with and over 4,000 women continue to die of cervical cancer annually in the United States. Over half of the new cervical cancer cases are diagnosed among women who have been never screened or who are infrequently screened, reflecting barriers presented by socioeconomic disparities, geographic inaccessibility, among other factors. An alternative screening approach that has been widely evaluated to overcome these barriers is self-collection of samples (‘self-sampling’) for HPV testing. This approach offers several benefits including ease of collection at a time/place of a woman’s choice without a need for a speculum examination or a clinic visit. This intervention has significant potential to expand cervical cancer screening access towards the ‘last mile’ for reaching never screened or under-screened women and thereby address a persistent cancer health disparity.
NCI DCP invites investigators and organizations interested in participating as clinical enrollment sites for the SHIP Trial to email CervicalCancerLastMile@mail.nih.gov for further information.
The National Cancer Institute (NCI)’s Cervical Cancer ‘Last Mile’ Initiative is a public private partnership bringing together federal agencies, industry partners, and professional societies/clinical practice guidelines organizations to contribute evidence informing the accuracy and clinical effectiveness of self-sampling-based HPV testing for primary cervical cancer screening, as well as accelerating progress towards regulatory approvals and adoption of this approach in clinical practice.
As part of the ‘Last Mile’ Initiative, the NCI Division of Cancer Prevention (DCP) is conducting a nationwide, multicentric screening trial, the “Self-sampling for HPV testing to Improve Cervical Cancer Prevention” Trial (‘SHIP Trial’) in diverse delivery settings to demonstrate the accuracy of self-sampling-based approaches as comparable (non-inferior) alternatives to provider-based collection of specimens for primary cervical cancer screening.
Overall coordination for the SHIP Trial is being supported by the Clinical Monitoring Research Program Directorate (CMRPD) of Leidos Biomedical Research, Inc., which operates NCI’s Frederick National Laboratory for Cancer Research (FNLCR), a Federally-Funded Research and Development Center (FFRDC).