Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and Tissue and Plasma Biomarkers of Hypoxia (CXTF10)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To understand the mechanisms by which hypoxia and IFP influence disease progression, and response to radiotherapy, chemotherapy and other novel biologically-targeted therapies in patients with cervix cancer.
研究概览
简要总结
The experiments outlined in this proposal will compare a number of currently available techniques for assessing hypoxia and interstitial fluid pressures in patients with cervix cancer. The aim of these experiments is to establish the relationship of the clinically relevant outcome measures of tumour control and survival following radiation therapy with these biological characteristics of carcinoma of the cervix relevant to tumour hypoxia. These characteristics will be assessed in patients undergoing treatment using techniques which have reached an appropriate level of development for clinical evaluation and aim to determine the best technique for determining these parameters of the tumour microenvironment. A number of novel strategies directed at the microenvironment are undergoing or soon will be undergoing clinical evaluation and selection of appropriate patients for these trials is of great importance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Histologic diagnosis of cervix cancer
- •A decision to treat using radiation therapy according to the existing treatment policies of the PMH Gynecology Group
- •Clinical stage IB-IV with grossly evident cervical disease
- •No distant metastases
- •No cytotoxic anti-cancer therapy for cervical carcinoma prior to study entry
- •Signed informed consent
排除标准
- 未提供
研究组 & 干预措施
Assays on cervical cancer tissue
干预措施: Tumour Biopsies and Blood Sampling (Other)
结局指标
主要结局
To understand the mechanisms by which hypoxia and IFP influence disease progression, and response to radiotherapy, chemotherapy and other novel biologically-targeted therapies in patients with cervix cancer.
时间窗: 3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.
次要结局
- To determine if plasma biomarkers of hypoxia are independent prognostic factors for relapse and survival in patients with cervix cancer.(3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.)
- To assess the heterogeneity of tissue biomarkers of hypoxia in multiple biopsies from cervix cancers.(3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.)
- To determine if tissue biomarkers of hypoxia are independent prognostic factors for relapse and survival in patients with cervix cancer.(3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.)