Clinical trial · Interventional
HPV Testing for Cervical Cancer Screening Study
A Randomized Controlled Evaluation of HPV Testing for Cervical Cancer Screening
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomised controlled trial of HPV testing with cytology triage for HPV positive women compared to liquid-based cervical cytology (LBC). Although LBC is not widely used for cervical cancer screening in Canada at present, the Pan-Canadian Cervical Cancer Forum has recommended its use and as it is likely to be the standard of care by the time these data are published, the trial has been designed to account for this. Further, LBC will improve the cost-effectiveness of HPV testing because the LBC medium is suitable for both HPV testing as well as cytology and thereby allows the triage testing to be undertaken from the same sample without having to recall the women.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer Screening | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positive | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Women with normal cytology at recruitment will be recalled for their next routine screen at 2 years and if negative again, for their exit screen at 4 years, all according to current provincial guidelines.
- interventionNames
- Procedure: Cervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positive
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Women with abnormal cytology at recruitment or at the 2 year screen will be followed according to provincial guidelines based on their cytology results.
- interventionNames
- Procedure: Cervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positive
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: Women from 25 to 65 years of age, registered with the Medical Services Plain in BC attending a collaborating healthcare provider for routine cervical screening in Metro Vancouver or Greater Victoria. Exclusion Criteria: 1. pregnant 2. history of invasive cervical cancer 3. no cervix 4. HIV positive or on immunosuppressive treatments 5. unable or unwilling to give informed consent 6. Treatment of moderate or greater dysplasia within last 5 years
References
Publications (1)
- DERIVEDSmith LW, Racey CS, Gondara L, Krajden M, Lee M, Martin RE, Stuart G, Peacock S, Coldman AJ, Franco EL, van Niekerk D, Ogilvie GS. Women's acceptability of and experience with primary human papillomavirus testing for cervix screening: HPV FOCAL trial cross-sectional online survey results. BMJ Open. 2021 Oct 7;11(10):e052084. doi: 10.1136/bmjopen-2021-052084. PMID 34620663