Clinical trial · Observational
E6/E7 mRNA Performance to Detect HSIL and Cost-effectiveness Analysis of This Screening Strategy in HIV + MSM
Performance of E6/E7 mRNA to Detect Anal High-Grade Intraepithelial Lesions and Cost-effectiveness Analysis of a New Screening Strategy for Anal Cancer in HIV Positive Men Who Have Sex With Men
- 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)
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 this new screening strategy. It is an ambispective study with 355 participants and a follow-up period of 2 to 5 years.
Conditions
Conditions (4)
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 Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Hiv | — | UNRESOLVED | — |
| HPV - Anogenital Human Papilloma Virus Infection | — | UNRESOLVED | — |
| HSIL, High Grade Squamous Intraepithelial Lesions | High Grade Squamous Intraepithelial Neoplasia | ALIAS | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine the predictive value of HPV E6/E7 mRNA for the detection of HSIL and its ability to predict incident cases.
- timeFrame
- 2-5 years
- description
- Determination of HPV E6/E7 ARNm in anal samples of 355 HIV + MSM. Correlation of the detection of HPV E6/E7 ARNm with the diagnosis of HSIL in this patients performing anal cytology an HRA at the first visit and during the follow-up.
Secondary outcomes (1)
- measure
- Cost-effectiveness analysis of an anal cancer screening strategy based on HPV E6/E7 mRNA analysis.
- timeFrame
- 2-5 years
- description
- Cost-effectiveness analysis of an anal cancer screening strategy based on the selection of candidates for HRA according to the expression of the E6 / E7 mRNA, compared to the usual strategy based on cytology and DNA HPV detection.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men who have sex with men \>= 18 years * HIV documented infection * Signature of the informed consent Exclusion Criteria: * 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.).
References
Publications (1)
- DERIVEDTorres M, Silva-Klug A, Ferrer E, Saumoy M, Trenti L, Tous S, Esteban A, Baixeras N, Catala I, Vidal A, G Bravo I, Podzamczer D, de Sanjose S. Detecting anal human papillomavirus infection in men who have sex with men living with HIV: implications of assay variability. Sex Transm Infect. 2023 May;99(3):187-190. doi: 10.1136/sextrans-2021-055303. Epub 2022 May 11. PMID 35545433