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临床试验/NCT03742375
NCT03742375终止不适用

Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
24
试验地点
2
主要终点
Incidence of HPV subtypes in HIV-positive patients

研究概览

简要总结

The pathophysiology from anal HPV infection to Anal Intraepithelial Neoplasia is less well understood than cervical HPV infection. In cervical screening programs it is well accepted that the sole presence of a high-risk HPV strain (irrespective of number of viral particles) is sufficient to justify further investigation and treatment. The investigators hypothesize that in anal HPV infection not only the presence but the extent of HPV infection (single genotype viral load) or combination of different HPV genotypes (cumulative viral load) is of importance in determining the risk of anal dysplasia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Incidence of HPV subtypes in HIV-positive patients

时间窗: 1 minute

Retrieval of 1 anal swab before performing HRA to determine the HPV subtypes at that particular moment

次要结局

  • Correlation between high-resolution anoscopy findings and quantitative HPV genotyping(30 minutes up to 10 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

prof. dr. Philip Roelandt

Assistant head of clinic Gastroenterology

Universitaire Ziekenhuizen KU Leuven

研究点 (2)

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