NCT00461760

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,223

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 13, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2007

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

10.2 years

First QC Date

April 13, 2007

Last Update Submit

June 18, 2019

Conditions

Cervical Cancer Screening

Keywords

HPV Screening/Testing for cervical cancer screening

Outcome Measures

Primary Outcomes (4)

  • Histologically confirmed greater than or equal to CIN2 detected at 2 years in both the control and the safety-check arms.

    2 years

  • Histologically confirmed greater than or equal to CIN3 detected over the 4 years post recruitment in the control and intervention arms will be evaluated and compared as a surrogate marker for estimating reductions in the incidence of cervical cancer.

    4 years

  • Detection of histologically confirmed greater than or equal to CIN3 in the participants allocated to 6-month retesting.

  • The total estimated cost per woman screened and the total estimated cost per quality-adjusted life-year gained for each technology.

Secondary Outcomes (2)

  • Clearance of HPV infection in women who are HPV positive at recruitment

  • HPV type specific prevalence in the screening population

Study Arms (2)

1

ACTIVE COMPARATOR

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.

Procedure: Cervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positive

2

ACTIVE COMPARATOR

Women with abnormal cytology at recruitment or at the 2 year screen will be followed according to provincial guidelines based on their cytology results.

Procedure: Cervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positive

Interventions

Cervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positivePROCEDURE

See Detailed Description.

1

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • pregnant
  • history of invasive cervical cancer
  • no cervix
  • HIV positive or on immunosuppressive treatments
  • unable or unwilling to give informed consent
  • Treatment of moderate or greater dysplasia within last 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Laurie Smith

Vancouver, British Columbia, V5Z 4G8, Canada

Location

BC Cancer

Vancouver, British Columbia, Canada

Location

BC Center for Disease Control

Vancouver, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Related Publications (1)

  • Smith 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: 34620663DERIVED

Study Officials

  • Andrew Coldman, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Gina Ogilvie, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Gina Ogilvie

Study Record Dates

First Submitted

April 13, 2007

First Posted

April 18, 2007

Study Start

March 1, 2007

Primary Completion

April 30, 2017

Study Completion

June 30, 2018

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations

CA(4)