NL-OMON54464招募中不适用
Role of host cell DNA methylation analysis in predicting non-regression or regression of high-grade anal intraepithelial neoplasia in HIV+ men trial (MARINE) - MARINE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Study group (N=200) - 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); - histopathological confirmed HGAIN (>=1
- •lesion); - satisfactory HRA at baseline, i.e. visualisation of entire
- •transformation zone with biopsies of all lesions; Substudy HIV-positive group
- •(N=20): - >18 years of age - Compliance to ART, undetectable viral load since
- •at least 1 year - A low nadir CD4 cell count (<200 cell/µl) -
- •Histopathologically confirmed HGAIN (>=1 lesion); - Satisfactory HRA at
- •baseline, i.e. visualisation of entire transformation zone with biopsies of all
- •lesions; Substudy HIV-negative group (N=20) - >18 years of age -
- •Histopathologically confirmed HGAIN (>=1 lesion); - Satisfactory HRA at
- •baseline, i.e. visualisation of entire transformation zone with biopsies of all
排除标准
- •Study group: - HGAIN covering more than 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. Substudy group (N=40): - 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); - Known active chronic infection such as hepatitis B or C - Diabetes
- •mellitus - Insufficient Dutch or English language skills. - Presence of any
- •diseases affecting the anal mucosa (fistulas, rhagades, eczema). - Signs of
- •current STI.
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