MDSC Clinical Assay for Cancer Detection and Monitoring in Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in MDSC level in patients with known metastatic renal cell carcinoma who undergo systemic treatment
研究概览
简要总结
This pilot research trial studies the use of the Myeloid Derived Suppressor Cells Clinical Assay in finding and monitoring kidney cancer. Studying samples of blood and urine from patients with kidney cancer in the laboratory may aid doctors in the early detection of cancer, monitor tumor response to therapy, detect the presence of occult spreading of disease, and identify early return of disease.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate a novel clinical assay (Myeloid Derived Suppressor Cells [MDSC] Clinical Assay) to detect cancer associated immune cells in the peripheral blood of patients as a means to better detect and monitor malignant renal cell carcinoma in patients.
II. Determine mean MDSC level, intra-subject variability, and inter-subject variability for three groups of subjects with variable renal cell carcinoma disease status at baseline.
III. In patients with known localized renal cell carcinoma who undergo nephrectomy, determine the change in MDSC level from diagnosis to after nephrectomy.
IV. In patients with known metastatic renal cell carcinoma who undergo systemic treatment, determine the change in MDSC level from baseline to after treatment (4 months) and, secondarily, to compare these changes to the changes in tumor burden as evaluated by computed tomography (CT) scan or other imaging modality.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects enrolled in this study must meet one of the 3 following criteria:
- •Group 1: Healthy individual with no history of cancer or hematuria
- •Group 2: Subject with a diagnosis of localized renal cell carcinoma (by imaging and eventual pathology) scheduled to undergo nephrectomy
- •Group 3: Subject with a diagnosis of metastatic renal cell cancer(by imaging and eventual pathology) who is scheduled to begin a new systemic therapy
- •Any type of renal cell carcinoma (RCC); any prior therapy
- •Performance status: 0-3
- •Leukocytes >= 3,000/mcL (frequently used - numbers listed are examples, investigator should modify as needed)
- •Absolute neutrophil count >= 1,500/mcL (frequently used - numbers listed are examples, investigator should modify as needed)
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •For normal subject arm: no evidence of cancer or hematuria
- •For localized RCC arm: no 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 RCC arm: no evidence of 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 all subjects: uncontrolled intercurrent illness including, but not limited to previous or current history of second malignancy unrelated to renal cell carcinoma; 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 known metastatic renal cell carcinoma who undergo systemic treatment
时间窗: Baseline to after 4 months of systemic treatment
The change in MDSC level in patients with known metastatic renal cell carcinoma who undergo systemic treatment will be determined. These changes will be compared to the changes in tumor burden as evaluated by CT scan or other imaging modality.
Mean MDSC level
时间窗: Baseline
The mean MDSC level, intra-subject variability, and inter-subject variability for three groups of subjects with variable renal cell carcinoma disease status will be determined at baseline.
Change in MDSC level in patients with localized renal cell carcinoma who undergo nephrectomy
时间窗: Baseline to 30 days after nephrectomy
次要结局
未报告次要终点