Cytology based screening for cervical cancer has effectively reduced cervical cancer incidence (70-80%) and mortality in countries with well organised screening programmes. Currently in Ireland there is no nationwide organised programme.
With the planned introduction of a national screening programme in 2008, cytology laboratories will be faced with a significant increase in workload. Currently, all laboratories have converted from conventional cervical smears to liquid based preparations. These monolayer liquid based preparations are ideal platforms for imaging. The Cytyc Imager is a computerised system, which identifies 22 fields for the cytology scientist to review using automated light microscopy. This compares with examining over 120 fields and hundreds of thousands of cells per slide with manual review.
This study aims to compare the effectiveness and reliability of Imager directed screening with manual screening in a prospective 3 centre randomised controlled trial. The trial will comprise 50,000 women screened manually and 50,000 women screened using the Imager and followed up for 3 years.
A study has already been completed where both manual and Imager have screened 20,000 women. The results of this study have shown Imager directed screening to be at least equivalent to manual screening while demonstrating a marked improvement in scientist productivity.
The 4 centre clinical trial prior to FDA approval of the Imager and numerous published studies to date has also shown equivalence or increased sensitivity and specificity.
It is our intention to also examine the Tripath Focalpoint GS imaging system. This system is however not yet FDA approved.
Imaging directed cytology has the potential not only to improve productivity and therefore address workforce issues, but also to address screening and interpretative issues, thereby providing better patient care.
