Evaluating BD Onclarity HPV Test for Detecting Anal Cancer and Precancer in Adults at Risk

What this Trial Is About

Researchers are evaluating the performance of the BD Onclarity HPV Assay on anal specimens to improve screening for anal cancer and precancerous lesions. Anal cancer is rare in the general population but more common in high-risk groups such as immunosuppressed individuals, men who have sex with men, and women with HPV-related genital tract diseases. Persistent infection with high-risk HPV types can lead to progression from precancerous lesions to invasive anal cancer. Currently, no HPV test is validated for anal samples, and screening methods vary without a uniform approach. The BD Onclarity HPV Assay is a real-time PCR test that detects DNA from 14 high-risk HPV types and provides detailed genotyping for six individual types and three groups of types. The test uses DNA extracted from anal samples and aims to enable less invasive anal cancer screening. The study includes subjects with both low-grade and high-grade anal intraepithelial neoplasia, invasive anal cancer, and individuals at increased risk due to immune status or medical history. Participants undergo testing with this assay to assess its accuracy. Participants may be patients with confirmed precancerous or cancerous anal lesions or those at high risk, including people with HIV, organ transplant recipients, men who have sex with men, women with prior genital HPV disease, and those with Crohns disease affecting the anal area. The study tracks the tests sensitivity and specificity over four years. Consent is required, and participants are monitored to help determine the tests usefulness in anal cancer screening programs.

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