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临床试验/NCT06574087
NCT06574087招募中不适用

Determining the Frequency of Occurrence and Defining the Most Appropriate Screening Test for Anal Intraepithelial Neoplasia (AIN) in Patients With Human Papillomavirus (HPV) Related Gynecological Diseases.

PCK Marine Hospital in Gdynia2 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2023年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
248
试验地点
2
主要终点
Anal intraepithelial neoplasm/ anal cancer

研究概览

简要总结

The primary aim of the study is to determine the total risk of AIN in group of HPV-RGD survivors and additionally to establish an exact risk for each of HPV-related gynecological precancers/cancers. Moreover, the most appropriate screening test for HSIL(AIN) in this group of patients will be determined. It will be effectuated by performing two kinds of tests: hrHPV test for the 14 most common oncogenic HPV types and the liquid cytology from both the lower genital tract and anal canal with subsequent high resolution anoscopy (HRA) with potential biopsy/excision of suspected lesions and histopathological examination.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • HPV related gynecological disease confirmed in histo-pathological examination
  • the posibility to obtain material from gynecological organ and from anal canal

排除标准

  • 未提供

结局指标

主要结局

Anal intraepithelial neoplasm/ anal cancer

时间窗: Just before surgery

Number of Participants with anal intraepithelial neoplasm/ anal cancer among patients with HPV-related gynecological diseases.

次要结局

未报告次要终点

研究者

发起方
PCK Marine Hospital in Gdynia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michal Brzezinski

MD

PCK Marine Hospital in Gdynia

研究点 (2)

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