Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- To develop, validate and refine high-throughput platforms for radiation biodosimetry using metabolomic assays.
研究概览
简要总结
The purpose of this study is to develop blood tests and urine tests that can tell doctors how much radiation a person has been exposed to. Doctors know how much radiation patients are exposed to in certain medical situations. An example of this would be radiation treatment for cancer. Radiation treatment machines are programmed to give exact doses of radiation.
详细描述
MSKCC patients undergoing TBI as part of a hematopoietic stem cell transplant (HSCT) will have blood drawn and urine collected for use in the validation and refinement of new methods for rapid high-throughput radiation biodosimetry. These blood and urine samples will be collected before, and at defined times after TBI. Blood sampling will occur in the same manner that it does during routine patient care during HSCT.
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
- 4 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients greater than 4 years of age at Memorial Sloan-Kettering Cancer Center
- •Must be undergoing hematopoietic stem cell transplantation (either autologous or allogenic) in conjunction with a conditioning regimen that includes TBI (single or multiple fraction)
- •Functional central venous catheter
排除标准
- •No subjects will be excluded from the proposed research study for demographic reasons. Treatment with growth factors, such as keratinocyte growth factor (KGF), will not be grounds for exclusion.
- •Subjects who will receive radiation therapy within 5 days prior to TBI will be excluded.
- •Subjects who will receive systemic antineoplastic chemotherapy within 7 days prior to TBI not have research bloods collected. Only urine will be collected from these patients.
- •Based on current knowledge, we will not a priori exclude patients based on disease status (ie, patients in or out of remission will be included in this study), type of disease(ie, chromosomal breakage syndromes), or previous therapies (unless exclusion criteria is met).
结局指标
主要结局
To develop, validate and refine high-throughput platforms for radiation biodosimetry using metabolomic assays.
时间窗: 3 years
The approach involves profiling blood and urinary metabolites that are specific for radiation exposure and dose.
次要结局
未报告次要终点