Valor de la detección del ARNM de los biomarcadores CDKN2A, MKI67, TOP2A en el diagnóstico precoz de cáncer en hombres que tienen sexo con hombres VIH positivos

Duración

2016 - 2018

Coordinador

Jaume Ordi

Financiadores

Ministerio de Ciencia, Innovación y Universidades. Instituto de Salud Carlos III Unión Europea Este proyecto está cofinanciado por el Fondo Europeo de Desarrollo Regional (FEDER). “Una manera de hacer Europa”

Objective

To evaluate and validate the usefulness of HPV identification followed by mRNA detection of selected biomarkers (CDKN2A, MKi67 and TOP2A) in the screening of anal carcinoma in HIV+ MSM patients.

Design

Observational, prospective, longitudinal study.

Subjects of the study

We will include in the study MSM/VIH+ referred to the Anal Cancer Prevention Unit of the Hospital Clinic/ISGlobal. The following study groups will be included: a) 100 HR-HPV negative patients; b) 100 HR-HPV positive patients with normal cytology; c) 150 HR-HPV positive patients with cytology of ASC or LSIL; d) 150 HR-HPV positive patients with cytology of LSIL; and e) 10 anal carcinomas.

Interventions

Initial recruitment visit with anal cytology. High resolution anoscopy to all patients with abnormal cytology or HR-HPV positive testing. Treatment of patients with HSIL/AIN2-3. One-year follow-up to all patients.

Methodology

• HPV detection and typing using Xpert HPV (Cepheid);
• RNA extraction from anal scrapping preserved in liquid based cytology.
• Identification by RT-PCR of the genotype specific E7 expression in the lesions included.
• Identification and quantitative analysis of mRNA expression of the genes CDKN2A, MKi67 and TOP2A by quantitative RT-PCR;
• Immunohistochemical analysis of CDKN2A, MKi67 and TOP2A;
• Correlation between the biomarker expression and HSIL/AIN2-3.

Total Funding

86.515,00 €

Project Code

PI15/00546