Rationale and design of the Prevent Anal Cancer Self-Swab Study: a protocol for a randomised clinical trial of home-based self-collection of cells for anal cancer screening.
Rationale and design of the Prevent Anal Cancer Self-Swab Study: a protocol for a randomised clinical trial of home-based self-collection of cells for anal cancer screening.
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DOI：
10.1136/bmjopen-2021-051118
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发表时间：
2021-06-29
期刊：
影响因子：
2.9
通讯作者：
Chiao EY
中科院分区：
文献类型：
--
作者：
Nyitray AG;Schick V;Swartz MD;Giuliano AR;Fernandez ME;Deshmukh AA;Ridolfi TJ;Ajala C;Brzezinski B;Sandoval M;Nedjai B;Smith JS;Chiao EY
肛门鳞状细胞癌是性少数男性中的常见癌症，特别是艾滋病毒阳性的性少数男性;然而，没有基于证据的国家筛查方案用于检测肛门癌前病变。我们的目的是确定每年的肛管自我采样或临床医生采样的人乳头瘤病毒（HPV）DNA的遵守。这是一项前瞻性、随机、两组临床研究，旨在评价每年一次的肛管脱落细胞家庭与诊所HPV DNA筛查的依从性。设置是以社区为基础的初级保健诊所。正在招募400名艾滋病毒阳性和艾滋病毒阴性的性少数男性和变性人，年龄>25岁，讲英语或西班牙语，目前除非甾体抗炎药外未使用抗凝剂，既往未诊断出肛门癌。受试者随机接受邮寄拭子，在0和12个月时在家采集肛管标本（组1），或在0和12个月时到诊所接受临床医生采集肛管标本（组2）。受试者将接受基于临床的数字肛门直肠检查和高分辨率肛门镜引导活检，以评估癌前病变，按研究组分层。研究中收集的肛门脱落细胞用于评估高危HPV持续性和宿主/病毒甲基化。主要分析将使用意向治疗原则，比较家庭和诊所组中遵守0个月和12个月采样的患者比例。先验的假设是，大多数人将遵守年度筛查与家庭为基础的臂与诊所为基础的arm. The研究已经由威斯康星州人类保护委员会医学院批准的人之间的依从性增加。调查结果将通过同行审查的文献和会议，向发生招募的社区传播。NCT 03489707。
Squamous cell carcinoma of the anus is a common cancer among sexual minority men, especially HIV-positive sexual minority men; however, there is no evidenced-based national screening protocol for detection of anal precancers. Our objective is to determine compliance with annual anal canal self-sampling or clinician-sampling for human papillomavirus (HPV) DNA. This is a prospective, randomised, two-arm clinical study to evaluate compliance with annual home-based versus clinic-based HPV DNA screening of anal canal exfoliated cells. The setting is primary care community-based clinics. Recruitment is ongoing for 400 HIV-positive and HIV-negative sexual minority men and transgender persons, aged >25 years, English or Spanish speaking, no current use of anticoagulants other than nonsteroidal anti-inflammatory drugs and no prior diagnosis of anal cancer. Participants are randomised to either receive a swab in the mail for home-based collection of an anal canal specimen at 0 and 12 months (arm 1) or attend a clinic for clinician collection of an anal canal specimen at 0 and 12 months (arm 2). Persons will receive clinic-based Digital Anal Rectal Examinations and high-resolution anoscopy-directed biopsy to assess precancerous lesions, stratified by study arm. Anal exfoliated cells collected in the study are assessed for high-risk HPV persistence and host/viral methylation. The primary analysis will use the intention-to-treat principle to compare the proportion of those who comply with 0-month and 12-month sampling in the home-based and clinic-based arms. The a priori hypothesis is that a majority of persons will comply with annual screening with increased compliance among persons in the home-based arm versus clinic-based arm. The study has been approved by the Medical College of Wisconsin Human Protections Committee. Results will be disseminated to communities where recruitment occurred and through peer-reviewed literature and conferences. NCT03489707.
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影响因子：
3.7
作者：
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通讯作者：
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DOI：
10.1097/00126334-200408010-00004
发表时间：
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