Performance analysis of an HPV test for anal cancer screening
Anal Cancer and/or Precancer Screening: Performance Analysis of the BD Onclarity HPV Assay on Anal Specimens
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06327568 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan
- European Institute of Oncology — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Fabio Bottari
- Email: fabio.bottari@ieo.it
- Phone: +390294372716
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.