RecruitingNCT06327568

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

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

Sponsor

European Institute of Oncology

Enrollment

200 participants

Start Date

Jun 17, 2022

Study Type

OBSERVATIONAL

Conditions

Anal Cancer High-Risk Cancer Anal Intraepithelial Neoplasia 2 Anal Intraepithelial Neoplasia 1

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests how well a specific HPV (human papillomavirus) test called the BD Onclarity™ assay works for detecting anal cancer and pre-cancerous lesions. Anal HPV-related cancers are rising, especially in high-risk groups. Researchers want to evaluate whether this test — used on anal swab samples — can reliably identify people at risk before cancer develops. **You may be eligible if...** - You are over 18 years old - You have confirmed anal pre-cancer (AIN1, AIN2+) or invasive anal cancer, OR - You are at high risk for anal cancer, such as: - People living with HIV or taking immunosuppressant drugs - Men who have sex with men (MSM) - Women aged 40+ with a history of cervical or vulvar pre-cancer or cancer - People with anal/peri-anal Crohn's disease - You are undergoing colorectal cancer screening **You may NOT be eligible if...** - You refuse to sign the consent form Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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