A Pilot Study of Early Changes in DNA Array Expression Following Chemo-Radiation Treatment of Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The goal of this clinical research study is to find out if the expression of certain genes is linked with the response of cervical cancer to radiation.
研究概览
简要总结
The goal of this clinical research study is to find out if the expression of certain genes is linked with the response of cervical cancer to radiation. Researchers will study a large number of genes located in tumor material to learn this information.
详细描述
Patients in this study are already scheduled to begin radiation therapy. Researchers will get tumor cells by taking two biopsies of the cervix. The first biopsy of the cervical tumor will be done before any treatment is given. The second biopsy will be performed about 48 hours after the radiation treatment has begun. They will then study the cells in the lab with a new technique for studying gene expression called DNA array, as well as human papillomavirus (HPV) analysis, quantification of apoptosis levels, hematoxylin and eosin staining, and storage of tissue for future research.
The patterns of gene expression in the biopsies will be compared with the success of radiation treatments.
Some of the material will also be stored and used in the future for other research projects.
This is an investigational study. A total of 18 patients will take part in this study. All will be enrolled at UTMDACC.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed cervical cancer: clinical Stage IB -IIIB
- •Invasive pure squamous cell carcinoma
- •Planned treatment with concurrent cisplatinum/5-fluorouracil chemotherapy and pelvic radiation
排除标准
- •Previous cervical cancer treatment including but not limited to transvaginal cone irradiation
结局指标
主要结局
The goal of this clinical research study is to find out if the expression of certain genes is linked with the response of cervical cancer to radiation.
时间窗: 8 Years
次要结局
- Researchers will study a large number of genes located in tumor material to learn this information.(8 Years)