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

NCT03713229 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2023-09-22

No results posted yet for this study

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.

Conditions

  • Anal Squamous Intraepithelial Neoplasia

Interventions

DIAGNOSTIC_TEST

Screening for anal squamous intraepithelial lesions

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

Sponsors & Collaborators

  • Instituto de Biomedicina de Sevilla

    collaborator UNKNOWN

  • Hospitales Universitarios Virgen del Rocío

    lead OTHER

Principal Investigators

  • Pompeyo Viciana, MD, PhD · Clínica El Sur

  • Karin Neukam, PharmD, PhD · Hospitales Universitarios Virgen del Rocío

  • César Sotomayor de la Piedra · Hospitales Universitarios Virgen del Rocío

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-01
Primary Completion
2025-12-31
Completion
2030-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03713229 on ClinicalTrials.gov