Collection of First-void Urine Samples for the Development of Standard Operating Procedures for Cervical (Pre)Cancer Biomarker Detection in First-void Urine: the BM-SOP Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Concentration of cervical cancer biomarkers in first-void urine
研究概览
简要总结
The aim of the study is to develop robust analytical protocols for first-void urine sample preparation and biomarker assays to analyze a panel of biomarkers in first-void urine for improved diagnosis of cervical (pre)cancer lesions.
详细描述
In total 100 women will be included in this trial, women diagnosed with abnormal cytology results and/or high risk HPV (Human Papillomavirus) infection scheduled for a colposcopy exam. These women are asked to collect a first-void urine sample with the Colli-PeeTM device, prior to their colposcopy exam at the clinic. The collected urine samples will be used for the development and optimisation of robust analytical protocols for first-void urine sample preparation and biomarker assays.
During colposcopy, the cervix will be visually inspected, whether or not combined with a biopsy for histological confirmation. Colposcopy is a procedure to identify abnormalities by using a colposcope that gives an illuminated, magnified view of the cervical region. It often includes rinsing the cervicovaginal region with 50 ml acetic acid (5%). Here, this fluid will be collected and serve as the intermediate step between biomarkers in cervicovaginal secretions and urine.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •25-64 year old
- •Women scheduled for a colposcopy exam due to abnormal cytology result according to the Bethesda classification 2001 (NILM, AGC (Atypical Glandular Cells), ASC-US (Atypical Squamous Cells of Undetermined Significance), ASC-H (Atypical Squamous Cells - cannot exclude HSIL), LSIL (Low-grade Squamous Intraepithelial Lesion), HSIL (High-grade Squamous Intraepithelial Lesion), invasive carcinoma), and/or positive for hrHPV infection. NILM (Negative for Intraepithelial Lesion or Malignancy) are only included when positive for hrHPV infection.
- •Signing informed consent form (ICF).
- •Giving consent to the research team (CEV) to contact his/her general practioner and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy (included in ICF).
排除标准
- •Participating in another clinical study at the same time of participating in this study.
- •Not able to understand the information brochure/what the study is about.
- •Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
结局指标
主要结局
Concentration of cervical cancer biomarkers in first-void urine
时间窗: Within 6 months after study completion
To detect candidate biomarkers (originally identified in cervical cells, tissue biopsies, and cervicovaginal fluid (CVF); HPV DNA type(s), viral load (copies/cel), proteins, (m)RNA, methylated (HPV and human) DNA, immunoglobulins; in first-void urine samples from 100 women scheduled for colposcopy due to abnormal cytology.
次要结局
- Concentration of cervical cancer biomarkers in VagLav samples versus first-void urine(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
Professor Pierre Van Damme, MD, PhD
Universiteit Antwerpen