ASIL, Anal squamous intraepithelial lesions Cancer
Conditions
Interventions
As this is a screening study, all participants undergo the same sampling and endoscopic examination procedures. At Södersjukhuset, anal samples for HPV PCR and cytology are collected using a Cytobrush
Sponsors
Ersta Diakoni
Eligibility
Sex/Gender
Male
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: MSM (Men who have sex with men) and transgender persons living with HIV, aged 18 years or older
Exclusion criteria
Exclusion criteria: 1. Rectal amputees 2. Do not speak Swedish or English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At baseline and each follow up: 1. The outcome of histopathological evaluation is into three groups: 1.1.HSIL (including Indefinite HSIL/LSIL), 1.2.LSIL, and 1.3.No Dysplasia (combining “no dysplasia in resected tissue” and “no lesions at index endoscopy”). 2. The outcome of HPV PCR is grouped into: 2.1.High-risk (Hr) HPV (including types 16 and 18), 2.2.Low-risk (Lr) HPV, and 2.3.No HPV (including cases with insufficient material). 3. The outcome of cytology evaluation is categorized as: 3.1.ASC-H, HSIL, Indefinite HSIL/LSIL, 3.2.ASCUS/LSIL, and 3.3.Benign (including Condyloma and insufficient material). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain is measured using visual analogue score (VAS) and Numerical Rating Scale (NRS) after anal sampling and endoscopy, in an anonymous questionnaire. NRS is used after endoscopy and documented. 2. The acceptability of flexible endoscopy of the anal canal and cytology and HPV testing measured using a questionnaire at each visit. | — |
Countries
Sweden
Contacts
Public ContactPeter Thelin Schmidt
Outcome results
None listed