Compass Trial: A Randomised Controlled Trial of Primary Human Papillomavirus (HPV) Testing for Cervical Cancer Screening in Australia: Pilot Study

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2013
INTERVENTION: Intervention Arm 2: Five ‐yearly HPV screening with types 16/18 (+/‐45 in pilot study) genotyping and cytology triage of intermediate risk women with other oncogenic HPV infection; The sample collected from participants in intervention arm 2 will be a Liquid Based Cytology (LBC) Pap test and collection should take 15 minutes and Intervention Arm 3: Five ‐yearly HPV screening with types 16/18 (+/‐45 in pilot study) genotyping and dual‐stained (DS) cytology (with p16/Ki67) triage of intermediate risk women with other oncogenic HPV infection. The sample collected from participants in intervention arm 3 will be a Liquid Based Cytology (LBC) Pap test and collection should take 15 minutes CONDITION: Cervical cancer Human Papillomavirus (HPV) PRIMARY OUTCOME: 1). To assess participant acceptance of the randomisation process and use of longer routine screening intervals, via recruitment rate. ; 2). To confirm the operational feasibility of laboratory processing procedures for each of the two HPV test platforms. ; 3). To assess positivity rates for the primary screening test in each arm, and estimate the cross sectional sensitivity and specificity of each screening approach for the detection of CIN 2+ and CIN 3+. ; SECONDARY OUTCOME: 4). To estimate the sensitivity and specificity of DS testing, in women positive for HPV ; INCLUSION CRITERIA: Australian female resident of Victoria Aged 25‐64 Attending for routine cervical screening at a participating health care practice
Epistemonikos ID: 2eb94f805ff29c74bd31f4cd92cc1ddff29d7714
First added on: Aug 25, 2024