Human papillomavirus (HPV) infection has been implicated as a necessary cause for the development of the majority of anogenital neoplasms which represent approximately 95% of anal tumors. Persistent high risk HR-HPV infection promotes progression from intraepithelial lesions high-grade squamous anal tumors (AIN) (H-SIL) to invasive anal tumors.
The diagnosis of AIN is made by cytology or biopsy during routine examinations. To date, no HPV test has been clinically validated for anal specimens and none are available in the molecular diagnostics market for this purpose.
The performance analysis of an HPV Test with simultaneous genotyping on anal samples could implement anal cancer screening without an invasive procedure and with one simple approach.
Subjects older than 18 years old
Subjects with histological-confirmed high-grade anal intraepithelial neoplasia (AIN2+) or anal invasive cancer
Subjects with histological-confirmed low-grade anal intraepithelial neoplasia (AIN1)
Immunocompromised subjects (patients with HIV infection, or taking immunosuppressive drugs, or post-organ transplantation)
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Patients who come at the European Institute of Oncology at high risk of anal cancer undergoing cancer screening anal, colorectal, or on an outpatient basis for HPV-related pathologies.
Case-control
Prospective
Not listed
Sensitivity and specificity of BD Onclarity HPV assay for HPV detection and genotyping in case/control patients.
To evaluate to use of BD Onclarity HPV assay for HPV detection and genotyping from the anus, without endoscope. This study aims to enroll 100 cases and 100 controls to evaluate the performance of the Onclarity test in detecting the presence of HPV in anal swab samples that will be placed in a Thin Prep vial (Hologic), in order to perform cytology and the BD Onclarity assay, a qualitative target-amplification test based on RT-PCR and fluorescent probe technology to detect E6 and E7 DNA regions of the HPV genome; Onclarity provides genotyping information on six individual genotypes (HPV 16, 18, 31, 45, 51 and 52) and reports the remaining HPV genotypes in three distinct groups (33/58, 35/39/68, and 56/59/66). The assay has an internal human beta-globin (HBB) gene control for sample adequacy and assay performance. Sensitivity, specificity of the Onclarity test will be evaluated.
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