Status:
UNKNOWN
E6/E7 mRNA Performance to Detect HSIL and Cost-effectiveness Analysis of This Screening Strategy in HIV + MSM
Lead Sponsor:
Hospital Universitari de Bellvitge
Collaborating Sponsors:
Institut d'Investigació Biomèdica de Bellvitge
Conditions:
HPV - Anogenital Human Papilloma Virus Infection
HSIL, High Grade Squamous Intraepithelial Lesions
Eligibility:
MALE
18+ years
Brief Summary
This study evaluates the positive and negative predictive value of E6/E7 mRNA expression for anal HSIL and its capacity to predict incident HSIL in HIV + MSM. We also analyse the cost-effectiveness of...
Detailed Description
Introduction: Anal cancer incidence is increasing in HIV-infected men who have sex with men (MSM). There are still no standardized criteria for anal cancer screening. Anal cytology has not shown enoug...
Eligibility Criteria
Inclusion
- Men who have sex with men \>= 18 years
- HIV documented infection
- Signature of the informed consent
Exclusion
- Previous diagnosis of anal cancer.
- Treatment of anal intraepithelial lesions the 5 years before study inclusion.
- Suspect infiltrating anal cancer, requiring exploration under anesthesia and surgical removal for histological confirmation.
- History of diffuse ano-genital condylomatous disease the 5 years before study inclusion or presence at first visit.
- Other factors that could prevent correct diagnosis and monitoring of the anal dysplastic lesions (test intolerance, proctological pathology that does not allow HRA, etc.).
Key Trial Info
Start Date :
January 11 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT03357991
Start Date
January 11 2015
End Date
June 1 2020
Last Update
December 7 2017
Active Locations (1)
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1
Hospital Universitary de bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907