MDSC Clinical Assay for Cancer Detection and Monitoring in Bladder Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in MDSC level in patients with no history of cancer
研究概览
简要总结
This pilot research trial studies how well myeloid derived suppressor cells (MDSC) clinical assay works in finding and monitoring cancer cells in blood and urine samples from patients with or without localized or metastatic bladder cancer. Studying samples of blood and urine from patients with or without bladder cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer and may help doctors improve ways to diagnose and treat patients.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate a novel clinical assay (MDSC clinical assay) to detect cancer associated immune cells in the peripheral blood of patients as a means to better detect and monitor malignant bladder cancer in patients.
II. Estimate mean MDSC level, intra-patient variability, and inter-patient variability, for 3 groups of subjects with variable bladder cancer disease status at baseline.
III. In patients with known localized, muscle-invasive bladder cancer who undergo surgical treatment: to determine the change in MDSC level from baseline to after treatment including surgery.
IV. In patients with known metastatic bladder cancer who undergo systemic treatment: to determine the change in MDSC level from baseline to after 4 cycles of treatment compared to the change in tumor burden as evaluated by radiographic imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet the criteria for one of the three following groups:
- •Normal patients- aged 40 years and older with no evidence of hematuria or cancer
- •Patients with localized bladder cancer diagnosed by cystoscopy and pathology: T2N0M0 or T3N0M0 who have not received neoadjuvant chemotherapy
- •Patients with metastatic bladder cancer: newly diagnosed with no previous treatment for metastatic disease
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •For normal subject arm: evidence of cancer or hematuria
- •For localized bladder cancer: evidence of metastatic disease, second cancer, prior chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- •For metastatic bladder cancer: prior therapy for metastatic disease
- •Uncontrolled intercurrent illness including, but not limited to previous or current history of second malignancy unrelated to bladder cancer; autoimmune disease or immune deficiency, chronic treatment with immunomodulatory therapies (e.g. glucocorticoids); significant trauma, surgery, or infection in the past two weeks or psychiatric illness/social situations that would limit compliance with study requirements
结局指标
主要结局
Change in MDSC level in patients with no history of cancer
时间窗: Baseline to 4 months
Change in MDSC level in patients with known localized, muscle-invasive bladder cancer who undergo surgical treatment
时间窗: Baseline to up to 4 months
Change in tumor burden evaluated by radiographic imaging
时间窗: Baseline to up to 1 year
Change in MDSC level in patients with known metastatic bladder cancer who undergo systemic treatment
时间窗: Baseline to up to 6 months
The direction and magnitude of the changes in Group 3 will be compared to the changes in tumor burden assessed radiographically - to explore the associations.
次要结局
- Change in urine cytology analysis(Baseline to up to 4 months)