European VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples and Urine Samples
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 6
- 主要终点
- Relative accuracy self-collected vaginal vs clinician-collected samples
研究概览
简要总结
The European VALHUDES study is a Clinical Performance /Diagnostic Test Accuracy Study that aims to evaluate whether HPV testing with new assays performed on self-samples, collected by means of a vaginal and a urine collection device is as accurate to detect cervical pre-cancer as on cliniciantaken cervical samples.
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 the Colli-Pee device) and a vaginal sample (with the FLOQSwab device), prior to undergoing colposcopy. Just before colposcopic examination, a clinician will also take a cervical sample (with a Cervex-Brush using the same procedure normally adopted for cervical cytology and/or HPV testing. During colposcopy, a colposcopy-targeted biopsy may be taken if appropriate. When according to colposcopy and biopsy results, an excisional treatment of a cervical precancer lesion is needed, the histology of the excised tissue will complete the end point of the study. The colposcopy and histological findings will be used as the gold standard if biopsies are taken.
In case of normal satisfactory colposcopic findings without biopsy taking, colposcopy will provide the study outcome.
Three new PCR-based HPV 'in vitro diagnostic devices' (Papilloplex, HPV Oncopredict RNA, HPV Oncopredict DNA) developed as part of the SME Instrument Project 'HPV OncoPredict (GA-806551)' will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women referred to colposcopy evaluation for any reason [i.e. previous history of abnormal cervical screen test results (cytology, HPV test), previous abnormal colposcopy]
- •Ability to understand and sign the informed consent
- •Informed consent given
排除标准
- •Age < 25 or > 65 years
- •Past history of hysterectomy
- •Women with known pregnancy
- •Pregnancy within last 3 months
- •Vulnerable patient: a patient who is or may be for any reason unable to take care of him or herself, or unable to protect him or herself against significant harm or exploitation
- •Simultaneous involvement in any other research project
结局指标
主要结局
Relative accuracy self-collected vaginal vs clinician-collected samples
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.
Relative sensitivity and specificity of each hrHPV DNA assay for detection of cervical intraepithelial neoplasia of grade II or worse (CIN2+) on self-collected vaginal vs on clinician-collected samples.
Relative accuracy urine vs clinician-collected samples
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.
Relative sensitivity and specificity of each hrHPV DNA assay for detection of cervical intraepithelial neoplasia of grade II or worse (CIN2+) on urine vs on clinician-collected samples.
次要结局
- Absolute accuracy for each sample type(One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.)
- Correlation viral load signals between different sample types(One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.)
- Absolute accuracy among hrHPV DNA-positive women(One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.)
- Questionnaire for the acceptance of self-collection(One day, at the day of colposcopy)
- Concordance of presence or absence of internal control gene between different sample types(One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.)
- Positivity rates human control gene(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 presence or absence of HPV genotypes between different sample types(One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.)
- Correlation internal control gene signals between different sample types(One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.)