跳至主要内容
临床试验/NCT05060640
NCT05060640招募中不适用

PREVALENCE OF ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS DETECTED BY ROUTINE COLONOSCOPY (PACCO STUDY)

University Fernando Pessoa1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年8月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Prevalence of anal high-grade squamous intraepithelial lesions in the squamocolumnar junction detected during routine colonoscopy.

研究概览

简要总结

HIV-positive patients, women with a history of genital neoplasia and patients under pharmacologically immunosuppression (e.g. transplanted recipients, Crohn´s disease and Lupus) are a high-risk population for anal human-papillomavirus infection and associated complications, like anal precancerous lesions and anal squamous cell carcinoma. There is a lack of information on the prevalence of anal precancerous detected by routine colonoscopy in this population, by evaluating the squamocolumnar junction (the most susceptible area for lesions) during this procedure. Given, the increasing incidence rates of anal squamous cell carcinoma expected for the next two decades and the increase number of at-risk patients, the possible benefit of routine endoscopy in the diagnosis of anal precancerous lesions needs to be further explored.

详细描述

Procedures in all patients:

  1. Digital anorectal evaluation
  2. Colonoscopy with retroflection and visualization of the anal squamocolumnar junction
  3. After identification of this area 5% acetic acid will be applied.
  4. Visualization under NBI/BLI.
  5. Biopsies of all the suspected lesions of anal high-grade squamous lesions (HSIL).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • HIV-positive patients
  • Solid transplanted recipients
  • Crohn's disease patients under immunosuppression: steroids, thiopurines, biologics
  • Patients with lupus under immunosuppression
  • Women with a previous history of genital neoplasia (high-grade lesions or cancer) in the cervix, vagina or vulva.

排除标准

  • Previous anal/perianal cancer history
  • Previous known history of anal/perianal intraepithelial neoplasia
  • Pelvic radiation

结局指标

主要结局

Prevalence of anal high-grade squamous intraepithelial lesions in the squamocolumnar junction detected during routine colonoscopy.

时间窗: through study completion, an average of 3 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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