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This paper describes the design and preliminary screening results of the HPV FOCAL Trial.
A database has been developed specifically for the HPV FOCAL trial.
The HPV FOCAL Trial design has been described previously [ 18] (Fig. 1).
The analyses in this paper were based only on CIN lesions identified among women referred to colposcopy as per the FOCAL trial protocol.
The HPV FOCAL trial is well positioned to examine the contribution of LBC with respect to primary HPV testing and inform the discussion internationally.
The study sample is placed in a ThinPrep PreservCyt vial (Hologic Inc, Bedford, MA, USA) and is used for all the HPV FOCAL trial testing.
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In this study, we compared the performance of the Digene Hybrid Capture® 2 High-Risk HPV DNA Test® (HC2) to that of the Roche cobas® 4800 HPV Test (COBAS) for primary cervical screening within the HPV FOCAL randomized trial.
Our current multicentre focal therapy trial incorporates all these focal therapy strategies and will aim to recruit 150 men [20].
Furthermore, it is essential to select validated and recommended questionnaires, to be able to compare the focal therapy trial outcomes.
A limitation of including intermediate- and high-risk men is their higher rate of micro-metastases and disease progression, even after radical therapy [42,43], which means including them in a focal therapy trial may increase the risk of early treatment failure, making it difficult to fully interpret treatment efficacy.
Since our early focal therapy trials formed some of the first trials and followed a phased programme [27], we decided to use TTPM biopsy to ensure, with a high degree of confidence, that clinically significant disease was not left untreated.
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