Validation of Tumor-Infiltrating T-Cells as a Biomarker for Advanced Epithelial Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Progression-free survival curves
研究概览
简要总结
This research study is looking at tumor tissue samples from patients who have undergone surgery for advanced stage III or stage IV ovarian epithelial cancer. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn how tumor infiltrating T cells can predict how patients will respond to treatment.
详细描述
PRIMARY OBJECTIVES:
I. To validate the ability of intratumoral tumor-infiltrating T lymphocytes (TILs) to predict progression-free survival (PFS) in patients with suboptimally debulked advanced stage III or IV ovarian epithelial cancer.
II. To validate the ability of intratumoral TILs to predict PFS in patients with optimally debulked disease.
SECONDARY OBJECTIVES:
I. To validate the ability of intratumoral TILs to predict overall survival of patients with suboptimally debulked disease.
研究设计
- 研究类型
- Observational
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage III or IV ovarian epithelial cancer and enrolled on Gynecologic Oncology Group (GOG)-0136 and a GOG front-line platinum/taxol chemotherapy trial (GOG-0114, GOG-132, GOG-0158, or GOG-0162)
- •Must have fixed and paraffin-embedded tissue from primary surgery available from 1 of the following sources:
- •Patients enrolled on GOG-0136 and a GOG front-line platinum/taxol chemotherapy trial(GOG-0114, GOG-0132, GOG-0158, and GOG-0162)
- •Patients who have had either optimal or suboptimal cytoreductive surgery
- •Patients for whom adequate demographic data, including major prognostic factors and follow-up information, were collected
- •Evaluable patients must have had measurable or nonmeasurable disease
- •Demographic and follow-up data available
排除标准
- 未提供
结局指标
主要结局
Progression-free survival curves
时间窗: Baseline
The Kaplan-Meier method will be used to estimate the survival curves, and the log-rank test will be used to test the difference between survival curves for TIL positive and negative patients. All of the tests will be two-sided and the significant levels will be set a 0.05.
Overall survival curves
时间窗: Baseline
The Kaplan-Meier method will be used to estimate the survival curves, and the log-rank test will be used to test the difference between survival curves for TIL positive and negative patients. All of the tests will be two-sided and the significant levels will be set a 0.05.
次要结局
未报告次要终点