Anal Cancer and/or Precancer Screening: Performance Analysis of the BD Onclarity HPV Assay on Anal Specimens
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of BD Onclarity HPV assay for HPV detection and genotyping in case/control patients.
研究概览
简要总结
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.
详细描述
Anal cancer is a rare disease in the general population, but its incidence is higher in certain at-risk groups, such as immunosuppressed individuals, including those with HIV infections and post-organ transplantation patients, men who have sex with men, and women with HPV-related lower genital tract dysplasia or cancer.
A squamous intraepithelial anal lesion is the dysplastic growth of squamous epithelial cells in the transition zone of the anal canal. This lesion is pre-malignant and can progress to anal squamous cell carcinoma if left untreated.
Human papillomavirus (HPV) infection has been implicated as the necessary cause for the development of the majority of anogenital malignancies accounting for approximately 95% of anal cancers. Persistent infection with HR-HPV promotes progression from high-grade squamous intraepithelial lesions (H-SIL) to invasive anal cancers. In the anal canal, low-grade intraepithelial lesion LSIL correlates with anal intraepithelial neoplasia (AIN)-1 or anal condyloma, while high grade squamous intraepithelial lesion HSIL correlates with AIN-2 and AIN-3.
Prevalence of H-SIL is around 40 to 50%. Progression from H-SIL to anal cancer is about 1/250 per year in HIV-positive MSM and 1/5000 per year in HIV-negative MSM, respectively.
The diagnosis of AIN is made from cytology or biopsy during routine examinations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 subjects (patients with HIV infection, or taking immunosuppressive drugs, or 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.
排除标准
- •Refuse to sign written consent.
结局指标
主要结局
Sensitivity and specificity of BD Onclarity HPV assay for HPV detection and genotyping in case/control patients.
时间窗: 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.
次要结局
未报告次要终点