Actively Recruiting
Anal Cancer and/or Precancer Screening: Performance Analysis of the BD Onclarity HPV Assay on Anal Specimens
Led by European Institute of Oncology · Updated on 2024-03-26
200
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
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 Crohn's disease affecting the anal area. The study tracks the test's sensitivity and specificity over four years. Consent is required, and participants are monitored to help determine the test's usefulness in anal cancer screening programs.
CONDITIONS
Brief Title
Anal Cancer and/or Precancer Screening: Performance Analysis of the BD Onclarity™ HPV Assay on Anal Specimens
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 immunocompromised individuals (HIV infection, immunosuppressive drugs, post-organ transplantation)
- Men who have sex with men (MSM)
- Women aged at least 40 years with a history of cervical intraepithelial neoplasia grade 2 or higher and/or vulvar cancer
- Subjects affected by anal and/or peri-anal Crohn's disease
- Subjects undergoing colorectal cancer screening
- Signed written consent
You will not qualify if you...
- Refusal to sign written consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 years
Participants who undergo routine care are observed to assess the performance of the BD Onclarity HPV Assay on anal specimens without invasive procedures.
Periodic visits depending on routine colorectal cancer screening schedules
Trial Site Locations
Total: 1 location
1
European Institute of Oncology
Milan, Italy
Actively Recruiting
Research Team
F
Fabio Bottari
C
Cristina Mazzon
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here