A phase II clinical study to assess the feasibility of self and partner anal examinations to detect anal canal abnormalities including anal cancer.
A phase II clinical study to assess the feasibility of self and partner anal examinations to detect anal canal abnormalities including anal cancer.
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DOI：
10.1136/sextrans-2017-053283
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发表时间：
2018-03
影响因子：
3.6
通讯作者：
Chiao EY
中科院分区：
文献类型：
--
作者：
Nyitray AG;Hicks JT;Hwang LY;Baraniuk S;White M;Millas S;Onwuka N;Zhang X;Brown EL;Ross MW;Chiao EY
肛门癌是男男性行为者（MSM）中常见的癌症;然而，肛门癌没有标准的筛查方案。我们进行了一项2期临床试验，以评估教授MSM识别肛管中可触及肿块的可行性，这是男性肛门癌的常见体征。一位擅长进行肛门直肠指检（DARE）的临床医生使用骨盆人体模型来训练200名年龄在27-78岁之间的MSM，如何为单身人士进行自我肛门检查（SAE）或为夫妇进行伴侣肛门检查（PAE）。然后，临床医生在没有立即披露结果的情况下进行了DARE，之后该男子或夫妇分别进行了SAE或PAE。计算SAE、PAE和总体的与临床医生DARE的一致率以及灵敏度、特异性、阳性预测值（PPV）和阴性预测值（NPV）。男性的中位年龄为52岁，42.5%为非洲裔美国人，60.5%为艾滋病毒阳性。DARE检测到12名男性的异常，而男性的SAE/PAEs检测到其中9名。共有93.0%的男性正确分类了他们的肛管健康（95%CI 89.5-96.5）。总体一致率、灵敏度和特异性分别为93.0%、75.0%和94.2%，而PPV和NPV分别为45.0%和98.3%。发现异常的6名男性的结节/肿块大小≥ 3 mm。超过一半的男性（60.5%）报告从未检查过肛门异常;然而，在进行SAE/PAE后，93.0%的人表示他们将来会重复检查。这些结果表明，在MSM中，通过自身或伴侣触诊可以检测到≥ 3 mm的肿瘤，并鼓励进一步研究，因为文献表明肛门癌肿瘤≤ 10 mm的治愈率很高。
Anal cancer is a common cancer among men who have sex with men (MSM); however, there is no standard screening protocol for anal cancer. We conducted a Phase 2 clinical trial to assess the feasibility of teaching MSM to recognise palpable masses in the anal canal which is a common sign of anal cancer in men. A clinician skilled in performing digital ano-rectal exams (DARE) used a pelvic mannequin to train 200 MSM, aged 27–78 years, how to do a self-anal exam (SAE) for singles or a partner anal exam (PAE) for couples. The clinician then performed a DARE without immediately disclosing results, after which the man or couple performed an SAE or PAE, respectively. Percent agreement with the clinician DARE in addition to sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated for the SAE, PAE, and overall. Men had a median age of 52 years, 42.5% were African American, and 60.5% were HIV-positive. DARE detected abnormalities in 12 men while the men’s SAE/PAEs detected nine of these. A total of 93.0% of men classified the health of their anal canal correctly (95% CI 89.5–96.5). Overall percent agreement, sensitivity, and specificity was 93.0%, 75.0%, and 94.2%, respectively, while PPV, and NPV were 45.0%, and 98.3%, respectively. The six men who detected the abnormality had nodules/masses ≥3mm in size. More than half of men (60.5%) reported never checking their anus for an abnormality; however, after performing an SAE/PAE, 93.0% said they would repeat it in the future. These results suggest that tumours of ≥3mm may be detectable by self- or partner palpation among MSM and encourage further investigation given literature suggesting a high cure rate for anal cancer tumours ≤10mm.
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DOI：
10.1097/00126334-200408010-00004
发表时间：
2004-08-01
影响因子：
3.6
作者：
Cranston, RD;Darragh, TM;Palefsky, JM
通讯作者：
Palefsky, JM
影响因子：
6
作者：
Ong, Jason J.;Fairley, Christopher K.;Clarke, Philip
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Clarke, Philip
影响因子：
7.4
作者：
Popadiuk, C;Pottle, M;Curran, V
通讯作者：
Curran, V
影响因子：
1.5
作者：
Newman PA;Roberts KJ;Masongsong E;Wiley DJ
通讯作者：
Wiley DJ
DOI：
10.1016/j.ijrobp.2004.09.060
发表时间：
2005-06-01
影响因子：
7
作者：
Ortholan, C;Ramaioli, A;Gerard, JP
通讯作者：
Gerard, JP