MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial (METEOR-CRATR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in tumor microenvironment
研究概览
简要总结
This study is a dynamically adjustable prospective longitudinal study designed to capture biospecimen (biopsy, blood, surgical) and multimodal treatment-related data (imaging, dosimetry, clinical) before, during, and after treatment with definitive-intent chemoradiotherapy for patients with locally advanced cervical and pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Confirmation of intent to receive radiotherapy for one of the following diagnoses:
- •Cervical cancer
- •Pancreatic cancer
- •ECOG performance status ≤ 2
- •At least 18 years old
- •Able to understand and willing to sign an IRB-approved written informed consent document
排除标准
- •Any issue (medical, anatomic, other) that might preclude safe acquisition of biospecimens at the discretion of the treating physician
研究组 & 干预措施
Pancreatic Cancer
- Patients will have blood and tumor collected at various time points throughout participation in the study.
- Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.
干预措施: Blood collection (Other)
Pancreatic Cancer
- Patients will have blood and tumor collected at various time points throughout participation in the study.
- Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.
干预措施: Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI) (Device)
Cervical Cancer
- Patients will have blood and tumor collected at various time points throughout participation in the study.
- Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.
干预措施: Tumor collection via biopsy (Other)
Cervical Cancer
- Patients will have blood and tumor collected at various time points throughout participation in the study.
- Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.
干预措施: Blood collection (Other)
Cervical Cancer
- Patients will have blood and tumor collected at various time points throughout participation in the study.
- Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.
干预措施: Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI) (Device)
Pancreatic Cancer
- Patients will have blood and tumor collected at various time points throughout participation in the study.
- Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.
干预措施: Tumor collection via biopsy (Other)
结局指标
主要结局
Changes in tumor microenvironment
时间窗: From start of follow-up through completion of follow-up (estimated to be 5 years)
Generalized linear mixed effects models will be first used to capture the changes in the longitudinal values of a single assay output over time for a given biospecimen. Random effects will be used to describe the correlation of repeated measures on the same subject over time.
次要结局
未报告次要终点