HSIL/ACIS/Early Cervical Cancer: What Are The Current Causative HPV Subtypes in the Era of HPV Vaccination?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reasons for vaccine failures
研究概览
简要总结
This study will look at cervical tissue samples in women with abnormal cervical cells to see if the frequency of the HPV 16/18 subtypes has changed in female populations today, after the introduction of the HPV vaccine. It will compare women who have been exposed to the HPV vaccine with those who have not.
详细描述
The development of cervical dysplasia (precursor to cervical cancer) and cervical cancer requires infection with one of several cancer causing subtypes of the human papilloma virus (HPV). There are over 100 subtypes of HPV, and most are not cancer causing. In the past, North American data has shown that 70% of early cervical cancers were associated with HPV subtypes 16 and/or 18. The first HPV vaccines to be approved protected against the common subtypes of HPV 16 and 18. The traditional HPV vaccination consists of 3-doses administered over a 6 month period.
Since the 8 years after the introduction of the vaccine, there have not been any studies analyzing HPV subtype changes. It is important to determine if the prevalence of the HPV subtypes associated with precancerous and/or early cervical cancer have changed, and what preventative outcomes have arisen from the HPV vaccination. This will have implications regarding the importance and anticipated effects of immunization with the nanovalent vaccine that includes other oncogenic subtypes.
This study will look at tissue samples to see if the frequency of the HPV 16/18 subtypes has changed in female populations today, after the introduction of the HPV vaccine. It will compare women who have been exposed to the HPV vaccine with those who have not.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 18 years old
- •Presenting with cervical high grade intraepithelial dysplasia (HSIL), adenocarcinoma in situ (ACIS), or early cervical cancer
- •Fulfills one of the following two criteria:
- •Expected to have a cervical biopsy, loop electrosurgical excision procedure (LEEP), or cone biopsy as part of standard of care treatment OR Has already had a cone biopsy of LEEP and the archived tissue is located at Sunnybrook Health Sciences Centre and was taken within two years from the time of consent.
排除标准
- •A history of HSIL, ACIS, or early cervical cancer prior to 2010
- •Patients who are unable to provide consent
- •Women who have had a previous LEEP or cone biopsy and tissue removed is greater than 2 years old, from the time of consent
- •women who have had a previous LEEP or cone biopsy and tissue is archived at an outside institution
结局指标
主要结局
Reasons for vaccine failures
时间窗: Baseline
A descriptive analysis to explore the potential reasons for HPV vaccine failures in women with HSIL/ACIS/early cervical cancer in patients who have been exposed to an HPV vaccine.
Overall prevalence of HPV subtypes
时间窗: Baseline
To determine the prevalence of HPV subtypes in HSIL/ACIS/early cervical cancer in patients who have been exposed or naïve to an HPV vaccine.
次要结局
未报告次要终点