Clinical Trial

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

Recruiting
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Record status
This record was last updated March 26, 2024 (before its estimated June 17, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-03-18.
Trial Details
NCT Number NCT06327568
Lead Sponsor European Institute of Oncology
Conditions Anal Intraepithelial Neoplasia 2, Anal Intraepithelial Neoplasia 1, Anal Cancer, High-Risk Cancer
Enrollment 200 participants
Start Date 2022-06-17
Primary Completion 2026-06-17 (estimated)
Study Completion 2029-06-17 (estimated)
Updated on ClinicalTrials.gov 2024-03-26