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Clinical Trials in Italy / NCT06327568
Recruiting Observational

Anal Cancer and/or Precancer Screening: Performance Analysis of the BD Onclarity™ HPV Assay on Anal Specimens

NCT06327568 · tracked via the Priya Life Science Italy tracker
Sponsor
European Institute of Oncology
Phase
Observational
Started
2022-06-17
Last updated
2024-03-26

Condition(s) studied

Anal Intraepithelial Neoplasia 2Anal Intraepithelial Neoplasia 1Anal CancerHigh-Risk Cancer

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Sensitivity and specificity of BD Onclarity HPV assay for HPV detection and genotyping in case/control patients. — 4 years
    To evaluate to use of BD Onclarity HPV assay for HPV detection and genotyping from the anus, without endoscope. This study aims to enroll 100 cases and 100 controls to evaluate the performance of the Onclarity test in detecting the presence of HPV in anal swab samples that will be placed in a Thin Prep vial (Hologic), in order to perform cytology and the BD Onclarity assay, a qualitative target-amplification test based on RT-PCR and fluorescent probe technology to detect E6 and E7 DNA regions of the HPV genome; Onclarity provides genotyping information on six individual genotypes (HPV 16, 18, 31, 45, 51 and 52) and reports the remaining HPV genotypes in three distinct groups (33/58, 35/39/68, and 56/59/66). The assay has an internal human beta-globin (HBB) gene control for sample adequacy and assay performance. Sensitivity, specificity of the Onclarity test will be evaluated.

Trial sites (1)

FacilityCityRegionStatus
European Institute of Oncology Milan Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06327568 on ClinicalTrials.gov ↗ ← All trials in Italy