Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and GSH Levels
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- To determine if tumour oxygen tension prior to and during radiation therapy is an independent prognostic factor for primary tumour response and control in patients with cervix cancer.
研究概览
简要总结
The aim of this study is to measure the oxygen content and interstitial fluid pressure in cervix cancer patients. Tumour oxygen content and internal pressure of tumours may be an important factor that influences the effectiveness of radiotherapy and other treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients with carcinoma of the cervix ( 3 cm in size or larger) where an examination under anesthesia is to be performed for staging purposes
- •Informed consent
排除标准
- •Patients with clinically occult cervix carcinoma
研究组 & 干预措施
Pre-treatment tumour oxygen measurements (under anesthesia)
干预措施: Pre-treatment tumour oxygen measurements (under anesthesia) (Procedure)
结局指标
主要结局
To determine if tumour oxygen tension prior to and during radiation therapy is an independent prognostic factor for primary tumour response and control in patients with cervix cancer.
时间窗: tumour measurement will be done 2-3 months following completion of treatment; follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter
To correlate tumour IFP measured before and during radiation therapy with oxygen tension as measured by the Eppendorf probe and to assess IFP as a prognostic factor for pelvic control.
时间窗: tumour measurement will be done 2-3 months following completion of treatment; follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter
次要结局
- To determine if whole cell or nuclear GSH levels are correlated with tumour oxygen tension and with tumour response and control.(follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter)