Anal Cancer and/or Precancer Screening: Performance Analysis of the BD Onclarity™ HPV Assay on Anal Specimens

Summary

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.

Eligibility

Inclusion Criteria:

* 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)
* Subjects at high-risk for anal cancers, including:

  1. Immunocompromised subjects (patients with HIV infection, or taking immunosuppressive drugs, or post-organ transplantation)
  2. Men who have sex with men (MSM)
  3. Women aged at least 40 years with a history of cervical intraepithelial neoplasia CIN2+ and/or vulvar cancer
  4. Subjects affected by anal and/or peri-anal localizations of Crohn's disease
* Subjects undergoing colorectal cancer screening
* Signed written consent.

Exclusion Criteria:

* Refuse to sign written consent.

Conditions5

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