Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Obtain pre- and post-irradiation participant-collect blood samples
研究概览
简要总结
Collect blood samples and associated clinical data prior to, during, and post radiation treatment.
详细描述
In order to further refine and independently validate the performance of DxTerity's test developed during the previous pilot study, the study will collect pre-, during, and post-irradiation blood samples and associated clinical and self-reported information from up to five hundred (500) subjects for analysis. Patients with a diagnosis of primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) cancer requiring radiation treatment to the primary disease site will be included in the study. Combining chemotherapy is allowed.
Blood samples for this study will be collected from cancer patients scheduled to undergo radiation therapy prior to and either during or after treatment. Approximately 150μL of blood per time point will be obtained via fingerstick remotely, from the participant's home or doctor's office; participation in this study will not affect any aspect of patient treatment. Samples will be collected using DxTerity's proprietary DxCollect® MCD Fingerstick Kit (MCD).
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
- •Male and female patients age 18 or older
- •Have a permanent address in the United States for the duration of the study
- •Diagnosed with a primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) cancer
- •Planned radiation therapy to the abdominal/pelvic area as part of clinical care
- •Able to provide informed consent
排除标准
- •Receipt of radiation within three (3) months to abdominal/pelvic area prior to scheduled start of Radiation Treatment
结局指标
主要结局
Obtain pre- and post-irradiation participant-collect blood samples
时间窗: 1.5 years
Obtain pre-irradiation participant-collected blood sample and associated clinical data from cancer patients undergoing abdominal/pelvic radiation therapy as part of clinical care.
次要结局
未报告次要终点