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
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 CIN2+ and/or vulvar cancer
- Subjects affected by anal and/or peri-anal localizations of Crohn's disease
- Subjects undergoing colorectal cancer screening
- Signed written consent.
You will not qualify if you...
- Refusal to sign written consent.
AI-Screening
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Trial Site Locations
Total: 1 location
1
European Institute of Oncology
Milan, Italy
Actively Recruiting
Research Team
F
Fabio Bottari
CONTACT
C
Cristina Mazzon
CONTACT
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
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