A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial)
A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial)
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DOI：
10.1186/1471-2407-10-111
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发表时间：
2010-03-24
期刊：
影响因子：
3.8
通讯作者：
Coldman, Andrew J.
中科院分区：
文献类型：
--
作者：
Ogilvie, Gina S.;van Niekerk, Dirk J.;Coldman, Andrew J.
背景：在 HPV FOCAL 试验中，我们将确定 hr-HPV DNA 检测作为独立筛查试验的有效性，然后对 hr-HPV 阳性女性进行液基细胞学 (LBC) 分类，与 LBC 进行比较，然后进行 hr-HPV 分类，结果为 >= CIN3。 方法/设计：HPV-FOCAL 是一项在不列颠哥伦比亚省进行的一项为期四年的随机、对照、三组研究。它将通过该省基于人口的宫颈癌筛查计划招募33,000名25-65岁的女性。对照组：在初始阴性结果和ASCUS病例的hr-HPV分类中，在入组时和两年时进行LBC，并在四年时结合LBC和hr-HPV；两年安全检查臂：入组时的 hr-HPV 和两年后的 LBC（对于 hr-HPV 阳性的 LBC 分类，初始结果为阴性的患者）；四年干预组：入组时进行 hr-HPV 检测，并在四年后对 hr-HPV 阳性病例的 LBC 分类初步阴性结果的患者进行 hr-HPV 和 LBC 讨论：迄今为止，6150 名参与者已完成样本和流行病学调查问卷。在纳入对照组的 2019 名女性中，1908 名 (94.5%) 的细胞学结果呈阴性。 25-29 岁的女性 HSIL 发病率最高（1.4%）。在安全组中，92.2% 的女性 hr-HPV 呈阴性，其中 25-29 岁女性的 hr-HPV 阳性率最高 (23.5%)。 HPV FOCAL 干预组也获得了类似的结果，这是北美第一个在基于人群的宫颈癌筛查计划中检查 hr-HPV 检测作为宫颈癌主要筛查的随机试验。
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 casesDiscussion: 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.