Detection of Biomarkers in First-void Urine Samples for Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- hrHPV DNA status of self-collected first-void urine and vaginal samples vs physician sampled cervical specimens.
研究概览
简要总结
The aim of this study is to analyse biomarkers in first-void urine for improved follow-up of women treated for high grade cervical intraepithelial neoplasia (CIN).
详细描述
In total 100 women, diagnosed with CIN2/3 and scheduled for LLETZ (Large Loop Excision of the Transformation Zone), will be included in this trial. These women are asked to collect two FV urine samples with the Colli-Pee device (Novosanis, Wijnegem, Belgium) prior to their treatment (one at home and one at the hospital) and at five additional time points post treatment (1-3-6-12-24 months) at home. In addition, five self-collected vaginal swabs will be taken, two before treatment (1 at home and 1 at the hospital) and three (6-12-24 months) after treatment at home. Qvintip devices are used for vaginal self-sampling.
During follow-up visits cervical samples and optional biopsies are collected by the physician and respectively send to the UZA anatomic pathology unit to determine the patient's HPV status, cytology and histology. For the study, one extra cervical sample will be taken by the physician just before treatment, that is not part of the normal standard procedure.
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 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female (18 years and older)
- •Scheduled for LLETZ treatment of diagnosed, histologically confirmed high grade CIN lesions
- •Giving informed consent to the research team (CEV) to contact his/her GP and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy.
- •Not participating in another clinical study where a drug or biological is administered.
- •Able to understand the information brochure/what the study is about.
排除标准
- 未提供
结局指标
主要结局
hrHPV DNA status of self-collected first-void urine and vaginal samples vs physician sampled cervical specimens.
时间窗: Within 6 months after study completion
Concordance hrHPV DNA status of self-collected first-void urine and vaginal samples from women treated for high-grade cervical lesions to that of physician sampled cervical specimens.
次要结局
- Validate the performance of additional biomarkers.(Within 6 months after study completion)
- hrHPV DNA status of self-collected first-void urine and vaginal samples at home vs at the hospital.(Within 6 months after study completion)
- Effect of treatment on HPV DNA presence.(Within 6 months after study completion)
- Preference of women for self-sampling methods.(Within 6 months after study completion)
研究者
Pierre Van Damme
Principal Investigator
Universiteit Antwerpen