Prevalence and associations of larger burden of intra-anal high-grade squamous intraepithelial lesions at baseline in an Australian cohort of gay and bisexual men: The Study of the Prevention of Anal Cancer

Templeton, David J; Williamson, Catherine; Jin, Fengyi; Hillman, Richard J.; Roberts, J. M.; Law, Carmella; Fairley, C; Garland, Suzanne M.; Grulich, Andrew E.; Poynten, I. Mary

doi:10.1016/j.canep.2019.101661

Cited by 2 publications

(3 citation statements)

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“…Anoscopists will study documentation and photography of previous visits to increase the likelihood of finding the same lesion again. An additional challenge is that repeated sampling through biopsies may influence the natural course of a lesion, potentially influencing the study outcome 26. Patients who are more concerned about their HGAIN lesions might not wish to participate in this study.…”

Section: Discussionmentioning

confidence: 99%

“…Participants must meet all following inclusion criteria: HIV+ patient at least 18 years of age; cisgender man, transgender man or transgender woman who has sex with men (further referred to as MSM); HGAIN (≥1 lesion) present at the first visit and thereafter confirmed by histopathology; satisfactory HRA at baseline, that is, visualisation of the entire transformation zone with biopsies of all visible lesions. The following exclusion criteria will be applied: HGAIN covering >50% of the circumference of the anal canal (progression to cancer of these patients is estimated to be considerable, and therefore withholding treatment would be unethical)7 26; clinical suspicion of anal cancer; diagnosis/history of anal cancer; treatment for HGAIN in the past 6 months; previous HPV vaccination; concomitant cancer and insufficient Dutch or English language skills. Since the proportion of recurring AIN episodes after treatment in current practice is high (>50% of cases), we will include participants with and without a history of (treatment for) AIN.…”

Section: Methods and Analysismentioning

confidence: 99%

“…An additional challenge is that repeated sampling through biopsies may influence the natural course of a lesion, potentially influencing the study outcome. 26 Patients who are more concerned about their HGAIN lesions might not wish to participate in this study. To minimise selection bias, the HRQoL control group, who will receive regular HGAIN treatment, will be recruited before inclusion of the study group in the same clinics and fulfilling the same eligibility criteria.…”

Section: Strengths Of This Studymentioning

confidence: 99%

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DNA Methylation Analysis to predict Regression of high-grade anal Intraepithelial Neoplasia in HIV+ men (MARINE): a cohort study protocol

et al. 2022

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IntroductionAnal cancer precursors, or high-grade anal intraepithelial neoplasia (HGAIN), are highly prevalent in HIV-seropositive (HIV+) men who have sex with men (MSM). Around 30% of lesions regress within 1 year, but current histopathological assessment is unable to distinguish between HGAIN likely to regress and HGAIN likely to persist or progress to cancer. We aim to assess if host cell DNA methylation markers can predict regression of HGAIN, thus determining the need for immediate treatment or active surveillance. This could reduce overtreatment and the associated anal and psycho-sexual morbidity.Methods and analysisThis is an active surveillance cohort study in three centres located in Amsterdam, the Netherlands, in 200 HIV+ MSM diagnosed with HGAIN. Participants will not be treated, but closely monitored during 24 months of follow-up with 6 monthly visits including cytology, and high-resolution anoscopy with biopsies. The primary study endpoint is histopathological regression of each baseline HGAIN lesion at the end of the study. Regression is defined as ≤low grade anal intraepithelial neoplasia in the exit biopsy at 24 months. Regression proportions in lesions with low versus high methylation levels (ASCL1, ZNF582), other biomarkers (HPV genotype, HPV-E4, p16INK4A, Ki-67) and immunological markers at baseline will be compared. Main secondary endpoints are the histological and clinical outcome (ie, the number of octants affected by HGAIN) of each baseline HGAIN lesion and overall HGAIN disease (i.e., all lesions combined) after each visit. The health-related quality of life of the study group will be compared with that of a control group of 50 HIV+ MSM receiving regular HGAIN treatment.Ethics and disseminationEthics approval was obtained from the Institutional Review Board of the Academic Medical Center (Amsterdam, The Netherlands; reference no. 2021_099). Participants are required to provide written informed consent. Findings will be disseminated through publication in peer-reviewed scientific journals and presentations at international scientific conferences; dissemination to policy makers and the target patient group will be achieved through our (inter-)national network, professional associations and collaboration with a patient representative organisation.Trial registration numberNL9664.

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Section: Discussionmentioning

confidence: 99%

Section: Methods and Analysismentioning

confidence: 99%

Section: Strengths Of This Studymentioning

confidence: 99%

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