Urinary and Serum VEGF and MMP Levels in Patients Receiving Radiation Therapy for Glioblastoma Multiforme: Prospective Determination of a Predictive Value for Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To determine if an increase in urinary VEGF and MMP level, from the end of treatment to a patient's one-month follow-up examination following radiotherapy is predictive of one-year recurrence in patients with Glioblastoma multiforme
研究概览
简要总结
This study will collect blood and urine samples from patients undergoing radiation therapy for glioblastoma multiforme (a type of brain tumor) to investigate the effects of this treatment on blood cells and certain proteins. The information from this study may help scientists develop new tests to measure radiation exposure and find new ways to treat cancer with radiation, and help determine which kinds of patients or tumors respond better to radiation therapy. Two proteins of particular interest in this study and which may be involved in the recurrence of cancer are VEGF (vascular endothelial growth factor) and MMPs (matrix metalloproteinases).
Patients 18 years of age and older with glioblastoma multiforme who are receiving or will receive radiation therapy as part of their medical treatment may be eligible for this study. Candidates are screened with a history and physical examination, blood tests, and magnetic resonance imaging (MRI) of the brain.
Participants will have blood and urine samples collected before, during and after completion of their radiation treatment. Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle in a vein. Additional samples may be requested at different times during treatment and in the 3-year follow-up period.
详细描述
BACKGROUND
- Preliminary data generated from our pilot protocol 02-C-0064 suggests that the urinary VEGF and MMP level at the one month follow-up time point compared to the last on-treatment time point collection may be predictive of tumor recurrence at one year.
- Note that this preliminary study included patients with all histologies.
- In an ongoing effort to validate our results with a larger more homogeneous patient cohort we propose to prospectively study patients undergoing radiotherapy for GBM.
OBJECTIVES
-We will determine whether VEGF and MMP level measurements aid in predicting tumor recurrence at 1 year.
ELIGIBILITY
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •Age greater than or equal to 18 years.
- •Histologically confirmed supratentorial Glioblastoma multiforme.
- •Karnofsky performance >
- •Patient must be a candidate for radiotherapy.
- •Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients with other cancers excluding non-melanomatous skin cancers or carcinoma in situ.
- •Gliadel wafer placement at the time of surgery.
- •Pregnancy because radiation has the potential for teratogenic or abortifacient effects.
研究组 & 干预措施
1/Glioblastoma multiforme patients
Patients with histologically confirmed supratentorial Glioblastoma multiforme
结局指标
主要结局
To determine if an increase in urinary VEGF and MMP level, from the end of treatment to a patient's one-month follow-up examination following radiotherapy is predictive of one-year recurrence in patients with Glioblastoma multiforme
时间窗: one year
Determine the whether VEGF and MMP level measurements aid in predicting tumor recurrence at 1 year.
次要结局
未报告次要终点