Study of The Examination of Sentinel Lymph Nodes for OX-40 Expression in Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- OX-40 expression
研究概览
简要总结
RATIONALE: Studying protein expression in sentinel lymph node tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help the study of cancer in the future.
PURPOSE: This laboratory study is evaluating OX-40 protein expression in the sentinel lymph nodes of patients with cancer.
详细描述
OBJECTIVES:
- Determine the qualitative and quantitative expression of OX-40 and related markers in sentinel lymph nodes previously removed from patients with cancer.
- Determine the qualitative and quantitative expression of OX-40 and related markers in sentinel lymph nodes freshly removed from patients with cancer.
- Correlate the expression of OX-40 and related markers in sentinel lymph node tissue with expression in nonsentinel tissue from primary tumors and nonsentinel lymph nodes, tumor stage, and patient outcomes.
OUTLINE: Sections of primary tumors, nonsentinel lymph nodes, and sentinel lymph nodes will be analyzed for expression of OX-40 by immunohistochemistry. Sections of negative (no tumor metastases) lymph nodes will be used as internal controls. Fresh tissue and blood will be tested for marker analysis and in vitro assays of immune function.
PROJECTED ACCRUAL: A total of 100 specimens from sentinel lymph nodes previously removed from cancer patients and 100 specimens from sentinel lymph nodes freshly removed from cancer patients will be accrued for this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
OX-40 expression
时间窗: During immunostaining
The first ten cases will be reviewed to assess the spectrum of OX-40 expression and to devise a semiquantitative scoring system. Each slide will be scanned in its entirety and then scored according to representative views with the greatest expression of immunostaining
Disease-free survival
时间窗: During data analysis
Kaplan-Maier method will be used to estimate the disease-free survival, and a log-rank test will be used to compare the disease-free survival between high vs. low OX-40 groups
次要结局
未报告次要终点