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ENROLLING BY INVITATION
NCT03713229

Seville Cohort of People Living With HIV at Risk for Anal Cancer

Sponsor: Hospitales Universitarios Virgen del Rocío

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

3000

Start Date

2010-09-01

Completion Date

2030-12-31

Last Updated

2023-09-22

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Screening for anal squamous intraepithelial lesions

digital-anorectal exam, liquid-based cytology, human papillomavirus testing, high-resolution anoscopy

Locations (1)

Virgen del Rocio University Hospital

Seville, Spain