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A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial) Ogilvie, Gina; van Niekerk, Dirk J.; Krajden, Mel; Martin, Ruth E.; Ehlen, Thomas G.; Ceballos, Kathy; Peacock, Stuart J.; Smith, Laurie W.; Kan, Lisa; Cook, Darrel A.; Mei, Wendy; Stuart, Gavin C.; Franco, Eduardo L.; Coldman, Andrew J.

Abstract

Background: In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. Methods/Design: HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion: To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5%) were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%). In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%). Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. Trial Registration: International Standard Randomised Controlled Trial Number Register, ISRCTN79347302

Item Metadata

Title
A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial)
Creator
Ogilvie, Gina; van Niekerk, Dirk J.; Krajden, Mel; Martin, Ruth E.; Ehlen, Thomas G.; Ceballos, Kathy; Peacock, Stuart J.; Smith, Laurie W.; Kan, Lisa; Cook, Darrel A.; Mei, Wendy; Stuart, Gavin C.; Franco, Eduardo L.; Coldman, Andrew J.
Publisher
BioMed Central
Date Issued
2010-03-24
Description
Background: In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. Methods/Design: HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion: To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5%) were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%). In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%). Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. Trial Registration: International Standard Randomised Controlled Trial Number Register, ISRCTN79347302
Genre
Article
Type
Text
Language
eng
Date Available
2016-01-19
Provider
Vancouver : University of British Columbia Library
Rights
Attribution 4.0 International (CC BY 4.0)
DOI
10.14288/1.0223543
URI
http://hdl.handle.net/2429/56591
Affiliation
Family Practice, Department of; Medicine, Faculty of; Obstetrics and Gynaecology, Department of; Pathology and Laboratory Medicine, Department of
Citation
BMC Cancer. 2010 Mar 24;10(1):111
Publisher DOI
10.1186/1471-2407-10-111
Peer Review Status
Reviewed
Scholarly Level
Faculty
Copyright Holder
Ogilvie et al.
Rights URI
http://creativecommons.org/licenses/by/4.0/
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Attribution 4.0 International (CC BY 4.0)