BMC Cancer | |
A randomized controlled trial of Human Papillomavirus (HPV) testing for cervicalcancer screening: trial design and preliminary results (HPV FOCAL Trial) | |
Study Protocol | |
Stuart J Peacock1  Lisa Kan2  Wendy Mei3  Ruth E Martin4  Gina S Ogilvie5  Thomas G Ehlen6  Gavin CE Stuart6  Kathy Ceballos7  Dirk J van Niekerk7  Mel Krajden8  Eduardo L Franco9  Darrel A Cook1,10  Laurie W Smith1,11  Andrew J Coldman1,12  | |
[1] Canadian Centre for Applied Research in Cancer Control, BC Cancer Research Centre, Vancouver, Canada;Cervical Cancer Screening Program, BC Cancer Agency, Vancouver, Canada;Clinical Trials Unit, Laboratory Services, Provincial Health Services Authority, Canada;Department of Family Practice, University of British Columbia, Vancouver, Canada;Department of Family Practice, University of British Columbia, Vancouver, Canada;Division of STI/HIV Prevention and Control, BC Centre for Disease Control, Vancouver, Canada;Department of Obstetrics and Gynecology, University of British Columbia, Vancouver, Canada;Department of Pathology and Laboratory Medicine, BC Cancer Agency, Vancouver, Canada;Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, Canada;Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, Canada;Division of Cancer Epidemiology, McGill University, Montreal, Canada;Hepatitis Services, BC Centre for Disease Control, Vancouver, Canada;Population Oncology, BC Cancer Agency, Vancouver, Canada;Population Oncology, BC Cancer Agency, Vancouver, Canada;Cervical Cancer Screening Program, BC Cancer Agency, Vancouver, Canada; | |
关键词: Cervical Cancer; Cervical Intraepithelial Neoplasia; Cervical Cancer Screening; High Grade Squamous Intraepithelial Lesion; Liquid Base Cytology; | |
DOI : 10.1186/1471-2407-10-111 | |
received in 2010-01-14, accepted in 2010-03-24, 发布年份 2010 | |
来源: Springer | |
【 摘 要 】
BackgroundIn 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/DesignHPV-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 casesDiscussionTo 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 RegistrationInternational Standard Randomised Controlled Trial Number Register, ISRCTN79347302
【 授权许可】
CC BY
© Ogilvie et al; licensee BioMed Central Ltd. 2010
【 预 览 】
Files | Size | Format | View |
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RO202311099193724ZK.pdf | 1300KB | download |
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