Anal Cancer and/or Precancer Screening: Performance Analysis of the BD Onclarity™ HPV Assay on Anal Specimens
Recruiting
Observational Study
Anal Intraepithelial Neoplasia 2
Anal Intraepithelial Neoplasia 1
Anal Cancer
High-Risk Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 200 (estimated)
- Sponsor
- European Institute of Oncology · Other
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About This Trial
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 d…
Trial Locations
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Eligibility 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, in…
Contacts