Pilot Study of Cancer Resistance in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Cell killing ability (positive or negative)
研究概览
简要总结
RATIONALE: Studying samples of blood and tissue in the laboratory from patients with cancer and from healthy participants may help doctors learn more about cancer.
PURPOSE: This laboratory study is looking at an assay in determining cancer resistance in patients with metastatic cancer and in healthy participants.
详细描述
OBJECTIVES:
- Optimize and standardize the in vitro cell kill assay using human white blood cells and human cancer cell lines from patients with metastatic cancer and from healthy participants.
- Determine the results of the in vitro cell kill assay in patients with metastatic cancer and in healthy participants with no history of cancer.
OUTLINE: This is a pilot study.
Peripheral blood is obtained from healthy participants and from cancer patients. Tissue is collected from archived samples. White blood cells are obtained from tissue and blood samples and are assessed by the in vitro cell kill assay.
PROJECTED ACCRUAL: A total of 24 patients and 24 healthy participants will be accrued for this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 120 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meets 1 of the following criteria:
- •Diagnosis of metastatic cancer including, but not limited to, any of the following:
- •Stage IV non-small cell lung cancer
- •Extensive-stage small cell lung cancer
- •Metastatic testicular cancer
- •Stage IV breast carcinoma
- •Stage III or IV ovarian carcinoma
- •Stage IV endometrial carcinoma
- •Stage IV prostate carcinoma
- •Stage IV colorectal or pancreatic cancer
- •Stage IV renal cancer
- •Stage III or IV non-Hodgkin's lymphoma
- •Stage IV bladder cancer
- •Stage III multiple myeloma (Salmon-Durie staging)
- •Metastatic melanoma
- •Metastatic sarcoma
- •Healthy participant, meeting the following criteria:
- •No prior cancer
- •Over 50 years of age
排除标准
- •Serious medical or psychiatric condition that would preclude study compliance
- •Chemotherapy or radiotherapy within the past 3 months (patient)
- •Prior immunosuppressive therapy or radiotherapy for any disease (healthy participant)
结局指标
主要结局
Cell killing ability (positive or negative)
时间窗: Day 180
Percentage of cells killed
时间窗: Day 180
次要结局
未报告次要终点
