Genotoxicity Assessment for Patients Receiving Large Field Irradiation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Measure the Change in MN-RET in the blood
研究概览
简要总结
The purpose of the research study is to evaluate an automated, laser-based technique for measuring DNA damage caused by radiation during cancer treatment in immature red blood cells.
详细描述
Correlative studies: analysis of RT effect on genotoxicity by assessing cytogenetic changes (dicentrics), micronucleated lymphocytes (MN-lymph), and micronucleated reticulocytes (MN-RET) using peripheral blood of patients receiving radiation.
i) document the kinetics by which radiation-induced MN-RET enter the peripheral blood stream.
ii) benchmark the MN-RET endpoint against current gold-standard biodosimetry endpoints-dicentrics and MN-lymphocytes.
iii) measure inter-individual variation in baseline and radiation-induced MN-RET frequencies.
iv) in collaboration with several FCM-equipped laboratories, evaluate the transferability of the human MN-RET scoring assay.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that are scheduled to begin radiotherapy to the large-field chest region are eligible if:
- •Daily radiation dose is between 1.8 and 5 Gy/day
- •Any single dimension of field size is ≥ 15 cm
- •Provision of written informed consent
- •Or patients receiving IMRT or Tomotherapy, when low-dose radiation is spread out to the normal tissues, irrespective of daily radiation doses.
- •Or patients receiving radionucleotides as part of the medical treatment (cancer or non-malignant conditions)
- •Or patients who will receive diagnostic CT scans, PET/CT scans, mammograms, or diagnostic imaging requiring radionucleotides
排除标准
- 未提供
结局指标
主要结局
Measure the Change in MN-RET in the blood
时间窗: Baseline and 1 day
次要结局
未报告次要终点
研究者
Yuhchyau Chen
Investigatory
University of Rochester