NCT03713229Enrolling by invitation
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 · Last updated 22 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 18 Oct 2018
- Start date
- 1 Sept 2010
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Hospitales Universitarios Virgen del Rocío
- Diseases
- HIV
- NCT number
- NCT03713229
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 1 Sept 2010 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Unable to provide informed consent
Who the study is looking for
- HIV infection as confirmed by ELISA and western blot
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virgen del Rocio University Hospital Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.