跳至主要内容
临床试验/CTRI/2019/08/020610
CTRI/2019/08/020610尚未招募不适用

Screening for anal intraepithelial neoplasia among men having sex with men attending a designated Sexually Transmitted clinic in South India

Indian Council of Medical Research ICMR1 个研究点 分布在 1 个国家目标入组 308 人开始时间: 2019年2月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
308
试验地点
1
主要终点
Frequency of anal intraepithelial neoplasia and its epidemiologic correlates

研究概览

简要总结

Ø Men who have sex with men (MSM), is at greater risk for anal cancer and its precursor lesions when compared to men in the general population.

Ø Incidence of anal cancer in MSM has been reported to be higher than the incidence of cervical cancer in women with the highest rates among HIV positive MSM in whom anal cancer rates are the highest.

Ø Almost upto 20% of patients with anal cancer are asymptomatic and the most common symptom reported is rectal bleeding which would be often attributed to haemorrhoids thereby further delaying the diagnosis. Epidemiologic studies have indicated that a             prolonged preclinical phase often precedes the onset of anal cancer in high-risk groups.

Ø The basic principle behind screening for anal dysplasia is the early identification of these proliferating cell lines that have established irreversible high-grade dysplasia or local invasive disease.

Ø Hence providing screening methods, especially for high-risk individuals, would provide an opportunity for earlier diagnosis and management of HPV and associated cytologic changes. These screening methods include anal Pap smears often combined with digital anorectal examination (DARE), to detect both palpable anatomic lesions as well as cytologic abnormalities followed by HPV detection and high resolution anoscopy and biopsy.

Ø Anal Pap smears have been found to have a sensitivity of 69% to 93%, and  specificity of 32% to 59% and have been reported to be cost-effective in detecting abnormal lesions in high-risk patients.However, the role of HPV detection in anal dysplasia screening remains controversial.

Ø HPV related anal dysplasia and cancer is a public health concern, just like other sexually transmitted infections and currently there are no national recommendations available for their screening. Due to the high rates of anal dysplasia and cancer in MSM, this study is proposed to identify the prevalence of AIN and to implement an effective screening program for this high risk population.

Aim:

To study the usefulness of screening tests and propose a screening strategy for the detection of anal intraepithelial neoplasia (AIN) and its epidemiologic correlates among men having sex with men (MSM) attending a designated sexually transmitted infection (STI) clinic in South India.

Objectives:

Among men having sex with men (homosexual and bisexual) attending a   designated STI clinic in South India,

1.     To study the frequency of anal intraepithelial neoplasia and its epidemiologic correlates.

2.     To study the diagnostic accuracy of anal “Pap†smears with p16 immunostaining, human papilloma virus (HPV) detection, and HRA findings in comparison with HRA guided biopsy findings as gold standard to detect anal intraepithelial neoplasia.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
Male

入选标准

  • Consecutive consenting men aged more than or equal to 18 years, attending the “Suraksha clinic†of the dermatology OPD of JIPMER identifying their sexuality as MSM (includes homosexual and bisexual men).

排除标准

  • Patients with known anal cancer Patients with fissure in ano and fistula in ano.

结局指标

主要结局

Frequency of anal intraepithelial neoplasia and its epidemiologic correlates

时间窗: At recruitment

Diagnostic accuracy of anal “Pap†smears with p16 immunostaining, human papilloma virus (HPV) detection, and HRA findings in comparison with HRA guided biopsy findings as gold standard to detect anal intraepithelial neoplasia

时间窗: At recruitment

次要结局

未报告次要终点

研究者

发起方
Indian Council of Medical Research ICMR
申办方类型
Government funding agency

研究点 (1)

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