HPV Testing for Cervical Cancer Screening Study (HPVFOCAL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00461760
First received: April 13, 2007
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: A Randomized Controlled Evaluation of HPV Testing for Cervical Cancer Screening

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Histologically confirmed greater than or equal to CIN2 detected at 2 years in both the control and the safety-check arms. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Detection of histologically confirmed greater than or equal to CIN3 in the participants allocated to 6-month retesting. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • The total estimated cost per woman screened and the total estimated cost per quality-adjusted life-year gained for each technology. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clearance of HPV infection in women who are HPV positive at recruitment [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • HPV type specific prevalence in the screening population [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment: 28000
Study Start Date: March 2007
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
See Detailed Description.
Active Comparator: 2
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
See detailed description.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00461760

Locations
Canada, British Columbia
Family Practice Units
Greater Vancouver Area, British Columbia, Canada
BC Cancer Agency
Vancouver, British Columbia, Canada
BC Center for Disease Control
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Andrew Coldman, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00461760     History of Changes
Other Study ID Numbers: H06-04032
Study First Received: April 13, 2007
Last Updated: December 13, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
HPV Screening/Testing for cervical cancer screening

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 16, 2014