A Pilot Study to Evaluate the PhageTech Virus BioResistor inDetecting Combinations of Bladder Cancer Biomarkers inPatients Under Active BCa Surveillance
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Successful identification of bladder tumor biomarkersBiomarkers in Patients Under Active BCa Surveillance
研究概览
简要总结
To evaluate the effectiveness of the PhageTech Virus BioResistor to detect bladder cancer biomarkers.
详细描述
This study will sample urine provided by bladder cancer patients as part of their normal routine surveillance screening. No additional effort will be required from the patients and only modest additional effort from the study staff. Some de-identified patient medical information may also be requested, including concominant medications, relevant current or previous diseases, prior bladder cancer interventions and other relevant information to ensure there are no interfering substances or other confounders that could affect study results. There is no risk to patients as the normal diagnostics for bladder cancer will be followed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Male and female patients ≥ 18 years
- •Previous bladder cancer diagnosis; any stage and histological type, undergoing cystoscopy
- •Patients with suspected bladder tumor undergoing surveillance cystoscopy
- •Patients must provide written Informed Consent.
排除标准
- •Patients unable or unwilling to sign the informed consent
- •Age < 18 years
- •Known HIV/HCV/HBV (information from clinical history).
结局指标
主要结局
Successful identification of bladder tumor biomarkersBiomarkers in Patients Under Active BCa Surveillance
时间窗: Up to 1 year
次要结局
未报告次要终点