Performance analysis of an HPV test for anal cancer screening
Official title: Anal Cancer and/or Precancer Screening: Performance Analysis of the BD Onclarity HPV Assay on Anal Specimens
Run by European Institute of Oncology · NCT06327568 · Data updated 2026-11-12
This study is testing a new HPV test on anal samples to see if it can help high-risk people find anal cancer and precancerous conditions more easily.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | June 17, 2022 |
| Main results expected | June 17, 2026 |
| Study ends | June 17, 2029 |
| Registry record updated | March 26, 2024 |
| Trial ID | NCT06327568 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals over 18 with confirmed high-grade anal intraepithelial neoplasia, anal cancer, or those at high risk for anal cancers.
✕Probably not a fit
Patients who do not have a confirmed diagnosis of anal intraepithelial neoplasia or anal cancer, or those who refuse to sign consent, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of the BD Onclarity™ HPV Assay on anal specimens to screen for anal cancer and precancerous conditions. It focuses on high-risk populations, particularly those with a history of HPV-related diseases or immunocompromised states. The study aims to validate a non-invasive HPV test that could simplify the screening process for anal cancer, which is currently diagnosed through cytology or biopsy. By analyzing anal samples, the study seeks to provide a more accessible method for early detection of anal intraepithelial neoplasia and anal cancer.
Why it matters
Potential benefit: If successful, this study could lead to a non-invasive screening method for anal cancer, improving early detection and patient outcomes.
How similar studies have gone: While there have been studies on HPV testing in other contexts, this specific approach for anal specimens is novel and has not been clinically validated before.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
European Institute of Oncology
Milan, Italy Recruiting
Study contacts
- Study coordinator: Fabio Bottari
- Email: fabio.bottari@ieo.it
- Phone: +390294372716
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.