HPV Primary Screening Pilot Study: molecular testing of potential triage strategies for HPV-positive women

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The CERVIVA HPV Primary Screening Pilot is exploring the use human papillomavirus (HPV) testing as a first-line cervical screening method. The current method of examining smear test samples is called PAP test where the cells from your smear test sample are looked at under a microscope to check for abnormalities. HPV testing is a slightly different way of examining your smear test sample. It involves a test that looks for the presence of Human Papillomavirus (HPV). HPV is a common virus that is linked with changes in the cells of the cervix (neck of the womb) and cervical cancer. Research has shown that HPV testing has many benefits over the PAP test. One benefit is that it can detect more cervical cell abnormalities than the PAP test can.

The presence of HPV does not always lead to the development of cervical cancer. To ensure HPV testing is effective, we need to find out which HPV positive samples are likely to develop into cancer. To do this, we will look into samples that test positive for HPV in a little more detail. We will do additional tests to look for specific markers that we know are linked to HPV infection. The additional tests will include cytology, HPV 16/18/45 genotyping, p16INK4a/ki67, methylation markers and RAMAN Spectroscopy. By following women to see what happens over the course of several smear tests, over 10 years, we will be able to determine how useful these new approaches to cervical screening are.

Project Partners/collaborators: Trinity College Dublin (Lead), CervicalCheck, The National Cervical Screening Programme, The Coombe Women and Infants University Hospital

Funding: Health Research Board, Ireland

Additional support: Hologic, Becton Dickonson, Seegene, Roche Diagnostics