Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples and First-void Urine Samples
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Analytical performance and Clinical accuracy
研究概览
简要总结
The "Extended VALHUDES" study is a Clinical Performance / Diagnostic Test Accuracy Study that aims to extend validation, achieved as part of the "Belgian VALHUDES", of HPV testing using BD Onclarity on samples collected using Copan's devices for dry self-sampling of vaginal material and for first-void urine: FLOQSwab® 5E089N and UriSponge™.
详细描述
Women accessing the Colposcopy Centres for a colposcopy examination and fulfilling the selection criteria will be asked, after written informed consent, to self-collect a first-void urine (with UriSponge™ 8E031S100 device) and a vaginal sample (with FLOQSwab® 5E089N device), prior to undergoing colposcopy. Just before colposcopic examination, a clinician will also collect a cervical sample using a Cervex-Brush.
A colposcopy-targeted biopsy or histology following excisional treatment of a cervical precancer lesion will be undertaken if appropriate. The colposcopy and/or histological findings will be used as the gold standard. In case of normal satisfactory colposcopic findings without biopsy taking, colposcopy will provide the study outcome.
Virological accuracy of HPV testing using: [a] BD Onclarity on FLOQSwab® 5E089N vaginal self-samples, [b] BD Onclarity on UriSponge™ 8E031S100 urine specimens, will be compared to BD Onclarity testing on a cervical samples collected by a clinician.
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 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women, referred to colposcopy due to abnormal Pap-test result, who agree to participate in the study by signing an informed consent form
排除标准
- •Women younger than 25 or older than 64 years of age
- •Hysterectomized women
- •Women with known pregnancy
- •Non-consenting women
- •Women that are not able to understand and/or sign the informed consent.
结局指标
主要结局
Analytical performance and Clinical accuracy
时间窗: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
Concordance of the presence of HPV and of the partial and extended HPV genotyping results applied on self- and clinician-collected samples.
次要结局
- Women's Acceptance and Preferences regarding urine collection, vaginal self-sampling or cervical sample collection by a clinician.(One day)