Evaluation Protocols for Isolation of Analytes From Urine for Future Oncology Applications
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Novosanis NV
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- General DNA or RNA concentration measured using Qubit
研究概览
简要总结
The aim of this study is to evaluate and optimize protocols for the isolation and analysis of analytes in urine (cell-free nucleic acids, extracellular vesicles and proteins). The following factors will be evaluated (1) volumetric collection with Colli-Pee®, a collection device developed by Novosanis for standardized collection of urine, and (2) stabilization methods.
This is a prospective study in which urine samples will be collected from healthy volunteers, urine samples and a blood sample from pregnant women and cancer patients with solid tumors with emphasis on breast- and prostate cancer. The participants will be asked to provide a urine sample collected with the Colli-Pee® device and fill out an online questionnaire to collect usability data. Thereafter, the urine sample will be aliquoted to be used in different pilot studies for the protocol optimization. For the pilot study where the effect of volume will be assessed, participants will be requested to collect multiple samples with different Colli-Pee® variants and fill out questionnaires accordingly.
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 specifically: patients suffering from local and systemic cancers (e.g. breast, prostate cancer)
排除标准
- •For cancer patients specifically: patients suffering from a blood cancer
结局指标
主要结局
General DNA or RNA concentration measured using Qubit
时间窗: Through study completion, an average of 1 year.
Comparison of DNA or RNA concentrations \[ng/µL\] measured using Qubit assays * between different extraction methods; * between different first-void urine volumes (10, 20, 40 mL); * between different storage conditions (Day 0, Day 7, Day 14 at room temperature).
Detection (presence/absence) of specific biomarker targets (SRY, HER2, PIK3CA, AR-V7, TMPRSS2-ERG) for pregnant women, breast cancer patients and prostate cancer patients measured using ddPCR
时间窗: Through study completion, an average of 1 year
Comparison of target detection measured using ddPCR assays \[copies/µL\] * between different extraction methods; * between different first-void urine volumes (10, 20, 40 mL\]; * between different storage conditions (Day 0, Day 7, Day 14 at room temperature).
cell-free DNA or RNA percentages and profiles measured using TapeStation
时间窗: Through study completion, an average of 1 year
Comparison of cell-free DNA or RNA percentages (%) and profiles (graphical) measured using TapeStation assays * between different extraction methods; * between different first-void urine volumes (10, 20, 40 mL); * between different storage conditions (Day 0, Day 7, Day 14 at room temperature).
Protein concentration measured using ELISA
时间窗: Through study completion, an average of 1 year.
Comparison of protein concentrations measured using ELISA assays * between different extraction methods; * between different first-void urine volumes (10, 20, 40 mL); * between different storage conditions (Day 0, Day 7, Day 14 at room temperature).
次要结局
- Detection (presence/absence) of specific biomarker targets (SRY, HER2, PIK3CA, AR-V7, TMPRSS2-ERG) for pregnant women, breast cancer patients and prostate 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)