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Protocol for Compass: a randomised controlled trial of primary HPV testing versus cytology screening for cervical cancer in HPV-unvaccinated and vaccinated women aged 25–69 years living in Australia
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  • Published on:
    Sample Size Revision - Protocol for Compass: a randomised controlled trial of primary HPV testing versus cytology screening for cervical cancer in HPV-unvaccinated and vaccinated women aged 25–69 years living in Australia
    • Karen Canfell, Director, Cancer Research Division, Cancer Council NSW. Co-principal Investigator of the Compass Trial. As per original publication.
    • Other Contributors:
      • Marion Saville, Executive Director VCS Foundation Ltd. Co-principal Investigator of the Compass Trial.
      • Michael Caruana, Senior Research Fellow
      • Val Gebski, Head of Biostatistics and Research Methodology, NHMRC Clinical Trials Centre
      • Jessica Darlington-Brown, Research Operations Manager
      • Julia Brotherton, Medical Director, VCS Population Health
      • Stella Heley, Senior Liaison Physician
      • Philip. E Castle, Professor

    The primary purpose of this response letter is to update the protocol to revise the sample size of the Compass Trial.


    Compass is a randomised controlled trial, operating alongside the Australian National Cervical Screening Program (NCSP). Under the auspices of the Independent Data Safety Monitoring Committee (IDSMC) and Scientific Advisory Committee (SAC) we have performed a re-analysis of our original estimate of the total trial sample size. This was prompted by two factors: (1) impact of the NCSP transition to primary HPV screening and (2) emergence of new evidence relevant to the sample size calculation. With consideration to the resource implications of the renewed program on trial recruitment and acknowledging that the original sample size of 121,000 women for the main trial was calculated in 2014 (prior to the emergence of new relevant evidence) the trial sample size was re-estimated.

    The sample size recalculation has resulted in a reduced recruitment target for the cohort of women in Compass Trial who were age-eligible for publicly funded HPV vaccination in Australia (the younger cohort) from 84,700 to 40,000 women; consequently the total recruitment target has been revised from 121,000 to 76,300. The updated sample size estimate has been approved by the Human Research Ethics Committee and is reflected in the trial registration ( Identifier: NCT02328872).

    (1) Impact of the NCSP transition to primary HPV scree...

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    Conflict of Interest:
    KC and MS are co-principal investigators of Compass. KC( co-principal investigator)and JDB and MC (project coordinator, project statistician) are on the Compass study team. Compass is conducted and funded by VCS Foundation, a government-funded health promotion charity. Neither KC, JDB, MC nor their institution on their behalf (Cancer Council NSW) receives any direct funding from industry for this trial or any other project. MS (coprincipal investigator), JB and SH report that their institution, VCS Foundation, received equipment and funding from Roche Molecular Systems and Roche Tissue Diagnostics, AZ, USA, during the conduct of the study. PEC reports non-financial support from Roche Molecular Systems, outside the submitted work. VG has no conflicts of interest to disclose.