NL-OMON22302尚未招募不适用
Role of host cell DNA Methylation Analysis in predicting non-Regression or regression of high-grade anal Intraepithelial NEoplasia in HIV+ men (MARINE) trial
Amsterdam UMC, location AMC0 个研究点目标入组 200 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •HIV+ patients of at least 18 years of age that are cisgender men, transgender men or
- •transgender women and who have sex with men (further referred to as HIV+ MSM);
- •-- Transgender men and women are an often neglected group in research, but
- •also at risk for anal HPV . Because of the comparable risk profile, we
- •assume that HIV+ transgender men and women who have sex with men have
- •a comparable chance of progression to anal cancer as cisgender HIV+MSM.
- •- histopathological confirmed HGAIN (=1 lesion);
- •- satisfactory HRA at baseline, i.e. visualisation of entire transformation zone with
- •biopsies of all lesions;
排除标准
- •- HGAIN covering >50% of the circumference of the anal canal (progression to cancer
- •of these patients is estimated as high and therefore withholding treatment would be unethical);
- •- clinical suspicion for anal cancer, defined as palpable abnormalities at DARE and
- •suspicion of invasion at MRI;
- •- histopathological diagnosis of anal cancer;
- •- history of anal cancer;
- •- previous HPV vaccination (including participants of the VACCAIN-T and VACCAIN-P trial);
- •- concomitant cancer;
- •- insufficient Dutch or English language skills.
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