Compass - Randomised Controlled Trial of Primary HPV Testing for Cervical Screening in Australia (Compass)
Cancer of the Cervix, Cervical Intraepithelial Neoplasia
About this trial
This is an interventional screening trial for Cancer of the Cervix focused on measuring screening, cervical screening, Human Papillomavirus (HPV), cancer prevention
Eligibility Criteria
Inclusion Criteria:
- Australian residents with a cervix, aged 25-69 years who are attending for routine cervical screening. (Note: since April 2016 recruitment has been confined to the younger strata, i.e. women age-eligible for HPV vaccination aged at least 25 and born on or after 1st July 1980, as the recruitment target of the older cohort was met).
- Participants may have been previously enrolled in the Compass Pilot but must have been discharged to routine screening. Women may also be in follow-up management for a previous abnormality or unsatisfactory cytology.
Exclusion Criteria:
- Previous total hysterectomy (uterus and cervix).
- The presence of symptoms or signs for which cervical cancer must be excluded.
- Currently undergoing treatment for cervical cancer.
- Currently enrolled in the Compass Pilot Study.
Sites / Locations
- VCS Foundation
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intervention (HPV Arm)
Control (LBC Arm)
Molecular testing for HPV with partial genotyping for types 16/18, with referral of the HPV16/18-positive group for diagnostic evaluation, and secondary randomisation of women testing positive for other oncogenic HPV infection (not 16/18), to either image-read cytology screening or dual-stained (DS) cytology testing with p16/Ki67 - the "HPV arm". Screening performed 5 yearly.
Image-read liquid based cytology (LBC) screening with reflex HPV triage testing for low grade smears, the "LBC arm." Screening performed 2.5 yearly.