Clinical trial · Observational
Seville Cohort of People Living With HIV at Risk for Anal Cancer
A Study to Screen for Anal Precancerous Squamous Intraepithelial Lesions and to Prevent Anal Cancer in a Real-life Setting of People Living With HIV at Different Risk: the Seville HIV Anal Cohort
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There is increasing awareness of augmenting risk of anal cancer in people living with HIV, especially among men who have sex with men (MSM). High resolution anoscopy (HRA) represents the gold standard to detect pre-cancerous anal high-grade squamous intraepithelial lesions (HSIL), however, the procedure is time-consuming, costly and, most importantly, the learning curve is very flat. This yields a poor implementation of anal screening and, likely, to an excess of otherwise preventable anal cancer. Other screening methods include digital ano-rectal examination, anal-rectal cytology and human papillomavirus (HPV) genotyping, since infection with high-risk HPV genotypes has been identified as the main reason for the development of HSIL. To date, there is no consensus in screening strategies. Furthermore, it remains unclear whether, in whom and to which extend the currently available topic and invasive treatment options for HSIL should be applied, given that the natural history of the development of anal cancer remains poorly understood. The present cohort study aims to provide real-life data on the screening, management and follow-up of HIV-infected MSM is warranted for a better understanding of anal cancer in this setting.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Squamous Intraepithelial Neoplasia | Anal Intraepithelial Neoplasia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Screening for anal squamous intraepithelial lesions | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- HIV-infected men who have sex with men
- description
- HIV-infected male patients who refer to conducting sexual risk practices that enable HPV transmission
- interventionNames
- Diagnostic Test: Screening for anal squamous intraepithelial lesions
- label
- HIV-infected men
- description
- HIV-infected male patients who neglect conducting sexual risk practices that enable HPV transmission
- interventionNames
- Diagnostic Test: Screening for anal squamous intraepithelial lesions
- label
- HIV-infected women
- description
- HIV-infected female patients disregarding sexual risk practices
- interventionNames
- Diagnostic Test: Screening for anal squamous intraepithelial lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * HIV infection as confirmed by ELISA and western blot Exclusion Criteria: * Unable to provide informed consent
References
Publications (4)
- RESULTWei F, Gaisa MM, D'Souza G, Xia N, Giuliano AR, Hawes SE, Gao L, Cheng SH, Dona MG, Goldstone SE, Schim van der Loeff MF, Neukam K, Meites E, Poynten IM, Dai J, Combes JD, Wieland U, Burgos J, Wilkin TJ, Hernandez AL, Iribarren Diaz M, Hidalgo-Tenorio C, Valencia Arredondo M, Nyitray AG, Wentzensen N, Chow EP, Smelov V, Nowak RG, Phanuphak N, Woo YL, Choi Y, Hu Y, Schofield AM, Woestenberg PJ, Chikandiwa AT, Hickey AC, de Pokomandy A, Murenzi G, Pere H, Del Pino M, Ortiz AP, Charnot-Katsikas A, Liu X, Chariyalertsak S, Strong C, Ong JJ, Yunihastuti E, Etienney I, Ferre VM, Zou H, Segondy M, Chinyowa S, Alberts CJ, Clifford GM. Epidemiology of anal human papillomavirus infection and high-grade squamous intraepithelial lesions in 29 900 men according to HIV status, sexuality, and age: a collaborative pooled analysis of 64 studies. Lancet HIV. 2021 Sep;8(9):e531-e543. doi: 10.1016/S2352-3018(21)00108-9. Epub 2021 Jul 30. PMID 34339628
- RESULTMilanes Guisado Y, Sotomayor C, Fontillon M, Dominguez Castano A, Espinosa N, Roca C, Lopez-Cortes LF, Viciana P, Neukam K; SeVIHanal Study Group. Incidence Rate and Risk Factors for Anal Squamous Cell Carcinoma in a Cohort of People Living With HIV from 2004 to 2017: Implementation of a Screening Program. Dis Colon Rectum. 2022 Jan 1;65(1):28-39. doi: 10.1097/DCR.0000000000002218. PMID 34694279
- RESULTViciana P, Milanes-Guisado Y, Fontillon M, Dominguez Castano A, Sotomayor C, Espinosa N, Lopez-Cortes LF, Neukam K. High-risk Human Papilloma Virus Testing Improves Diagnostic Performance to Predict Moderate- to High-grade Anal Intraepithelial Neoplasia in Human Immunodeficiency Virus-infected Men Who Have Sex With Men in Low-to-Absent Cytological Abnormalities. Clin Infect Dis. 2019 Nov 27;69(12):2185-2192. doi: 10.1093/cid/ciz144. PMID 30770528
- RESULTNeukam K, Milanes Guisado Y, Fontillon M, Merino L, Sotomayor C, Espinosa N, Lopez-Cortes LF, Viciana P; SeVIHanal Study Group. High-resolution anoscopy in HIV-infected men: Assessment of the learning curve and factors that improve the performance. Papillomavirus Res. 2019 Jun;7:62-66. doi: 10.1016/j.pvr.2019.01.003. Epub 2019 Feb 1. PMID 30716543