A randomized controlled trial of Human Papillomavirus (HPV) testing for cervicalcancer screening: trial design and preliminary results (HPV FOCAL Trial)

BMC Cancer

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 Cook^1,10  Laurie W Smith^1,11  Andrew J Coldman^1,12 

[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