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HPV Testing for Cervical Cancer Screening Study (HPVFOCAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00461760
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Gina Ogilvie, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: A Randomized Controlled Evaluation of HPV Testing for Cervical Cancer Screening
Study Start Date : March 2007
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Detection of histologically confirmed greater than or equal to CIN3 in the participants allocated to 6-month retesting.
  4. The total estimated cost per woman screened and the total estimated cost per quality-adjusted life-year gained for each technology.

Secondary Outcome Measures :
  1. Clearance of HPV infection in women who are HPV positive at recruitment
  2. HPV type specific prevalence in the screening population


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461760


Locations
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Canada, British Columbia
Laurie Smith
Vancouver, British Columbia, Canada, V5Z 4G8
BC Cancer
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
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Principal Investigator: Andrew Coldman, PhD University of British Columbia
Principal Investigator: Gina Ogilvie, MD University of British Columbia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gina Ogilvie, Dr. Gina Ogilvie, University of British Columbia
ClinicalTrials.gov Identifier: NCT00461760    
Other Study ID Numbers: H06-04032
First Posted: April 18, 2007    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Keywords provided by Gina Ogilvie, University of British Columbia:
HPV Screening/Testing for cervical cancer screening
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases