Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14,935
- 试验地点
- 59
- 主要终点
- Disease Progression greater than or equal to (cervical intraepithelial neoplasia) CIN3
研究概览
简要总结
A prospective multicenter interventional study will be conducted to enroll women undergoing routine cervical cancer screening to collect cervical liquid-based cytology (LBC) specimen(s). For all subjects, two cervical specimens will be collected, and one placed into Hologic ThinPrep Pap Test collection kit with PreservCyt Solution (also referred to as ThinPrep specimen) and the other into BD SurePath liquid-based Pap test (also referred to as SurePath specimen). Cytology and HR HPV results will be generated and utilized to determine need for subject referral to colposcopy. Collection of an endocervical curettage (ECC) specimen, and biopsy(ies) if applicable, from women who are referred to colposcopy as a follow up will be conducted according to a standardized protocol. Disease status for each subject will be determined based on cytology, HPV test results, and/or consensus histology review of cervical biopsy specimens.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women is eligible if she meets the following:
- •Is 25 years of age or older
- •Is attending a participating clinic for routine cervical cancer screening following screening guidelines
- •Has an intact cervix
- •Is willing and able to provide documented informed consent
- •Is willing and able to undergo colposcopy, biopsy, and endocervical curettage (ECC) within 12 weeks (≤ 84 days) from the baseline visit, if required
- •Is willing and able to allow collection of two cervical cytology specimens
排除标准
- •A women is ineligible for the study if she meets any of the following criteria:
- •Is pregnant at the time of visit or plans to become pregnant within the following 12 weeks
- •Has any known medical condition that, in the opinion of the investigator, would result in increased risk of bleeding at biopsy
- •Has a known history of excisional or ablative therapy (e.g., LEEP, cone biopsy, cervical laser surgery, or cryotherapy) to the cervix in the last 12 months prior to the baseline visit
- •Had a cervical cytology specimen collected within the last 4 months
- •Is currently participating in any diagnostic trial for cervical cancer
- •Had a complete or partial hysterectomy, either supra cervical or involving removal of the cervix
- •Is currently participating or planning to participate in any clinical trial for HPV treatment (for the duration of this study)
- •Previous participation in this study
结局指标
主要结局
Disease Progression greater than or equal to (cervical intraepithelial neoplasia) CIN3
时间窗: Baseline to 12 weeks
Diagnosis of greater than or equal to CIN3 (cervical intraepithelial neoplasia) is based on central pathology review panel histologic result.
次要结局
- Disease progression greater than or equal to cervical intraepithelial neoplasia (CIN2)(Baseline to 12 weeks)