Bladder Bank (a Prospective Banking Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Blood sample to support the development of non-invasive tests for early detection of bladder cancer
研究概览
简要总结
This study collects blood and urine samples from patients with bladder cancer to support the development of tests for early detection of bladder cancer.
详细描述
PRIMARY OBJECTIVE:
I. To establish a biobank of samples (blood and urine) to support the development of non-invasive tests for early detection of bladder cancer.
OUTLINE: This is an observational study.
Patients undergo blood and urine sample collection and have their medical records reviewed while on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patient has undergone office-based evaluation for hematuria [computed tomography (CT), ultrasound, cystoscopy]
排除标准
- •Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible)
- •Patient has recurrent muscle invasive bladder cancer
- •Patient has ever been previously diagnosed with UTUC (upper tract urothelial carcinoma) prior to bladder resection
- •Patient has received chemotherapy class drugs for the treatment of non-target origin cancer in the 5 years prior to current collection
- •Patient has had any prior radiation therapy to the target lesion prior to current collection
- •Patient has had a biopsy to the target organ and/or lesion within 3 days before collection
- •Patient has undergone cystectomy or cystoprostatectomy
- •Patient has transurethral instrumentation (placement of urinary catheter) within 7 days prior to urine collection
- •Patient has had a urinary tract infection within 14 days prior to urine collection
- •Patient has chronic indwelling urinary catheter
研究组 & 干预措施
Observational
Patients undergo blood and urine sample collection and have their medical records reviewed while on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Blood sample to support the development of non-invasive tests for early detection of bladder cancer
时间窗: Baseline (at enrollment)
At study enrollment for subjects, 60 ml (4 tablespoons) of blood will be drawn from all participants and processed according to standardized study biospecimen protocol. All samples will be stored for future analysis in Molecular Cancer Diagnostic Laboratory at Mayo Clinic.
Urine sample to support the development of non-invasive tests for early detection of bladder cancer
时间窗: Baseline (at enrollment)
At study enrollment for subjects, up to 20mL of urine will be collected from the same or unique case patients identified for blood collection. All samples will be stored for future analysis in Molecular Cancer Diagnostic Laboratory at Mayo Clinic.
次要结局
未报告次要终点