Investigation of Urinary Biomarkers for the Detection of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Novosanis NV
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Detection (presence/absence) of specific urinary biomarker targets (HER2, PIK3CA) for breast cancer patients measured using ddPCR.
研究概览
简要总结
The aim of this study is to investigate and possibly validate urinary biomarkers for breast cancer. During this study the focus will be on aberrations of selected genes as prognostic or predictive value has been shown for these genes in tissue, CTC or blood derived cfDNA. Proteins will be explored in urine as well.
This is a prospective study in which urine samples will be collected from healthy volunteers and urine samples and a blood sample from cancer patients with breast cancer. The participants will be asked to provide a urine sample collected with the ColliPee® device and fill out an online questionnaire to collect usability data. Thereafter, the urine sample will be aliquoted to be used in the study to investigate the different urinary analytes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being at least 18 years old
- •Being able to understand and read Dutch
- •For cancer patients: diagnosed with breast cancer
排除标准
- •For cancer patients: suffering from a blood cancer
- •For healthy volunteers: diagnosed with cancer
结局指标
主要结局
Detection (presence/absence) of specific urinary biomarker targets (HER2, PIK3CA) for breast cancer patients measured using ddPCR.
时间窗: Through study completion, an average of 1 year.
Comparison of target detection measured using ddPCR assays \[positive, negative or copies/µL\] in first-void urine samples from breast cancer patients compared to age- and sex-matched healthy volunteers. (Proof of concept study)
次要结局
- Detection (presence/absence) of specific biomarker targets (HER2, PIK3CA) for breast cancer patients measured using ddPCR.(Through study completion, an average of 1 year)
- Usability characteristics of the Colli-Pee UAS devices.(Through study completion, an average of 1 year)