Breast Radiation-induced Immunologic Genomic Hypofractionated Temporal Radiation Alterations DNA Damage (BRIGHT-RAD) Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Percent change of CD8+ T cells
研究概览
简要总结
This study assesses changes to the immune cells following hypofractionated radiation-induced DNA damage in breast cancer patients. Radiation therapy may cause immune cells to enter tumors and target cancer cells. The goal of this study is to measure the change in the level of immune cells in the tumor before and after radiation therapy.
详细描述
PRIMARY OBJECTIVE:
I. To estimate the percent change in immune infiltration at day 3 and day 7 of radiotherapy (RT) relative to baseline (before radiotherapy).
SECONDARY OBJECTIVE:
I. To estimate the degree of deoxyribonucleic acid (DNA) damage at approximately 3 and 7 days after radiotherapy compared to baseline.
II. To examine cancer cell intrinsic immune signaling following radiotherapy.
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 >= 18 years of age with biopsy proven invasive breast cancer
- •Breast cancer that appears to be superficially accessible to a tumor punch biopsy
- •Patients thought to derive clinical benefit from palliative RT to the breast/chestwall
- •In discussions with the medical oncologist, if clinically reasonable, systemic therapy will be held during RT
排除标准
- •A history of prior radiation to the area requiring radiation for which the attending physician believes reirradiation could not be safely delivered
- •Pregnancy
- •Active usage of anticoagulant medications that are considered to pose an increased risk of tumor punch biopsies
- •Receipt of immunotherapy or chemotherapy 7 days prior to start of RT
研究组 & 干预措施
Observational (RT, biopsy)
Patients undergo RT on day 1. Patients also undergo tumor punch biopsies and blood sample collection prior to the first fraction and on days 1, 3, and 7.
干预措施: Biopsy (Procedure)
Observational (RT, biopsy)
Patients undergo RT on day 1. Patients also undergo tumor punch biopsies and blood sample collection prior to the first fraction and on days 1, 3, and 7.
干预措施: Biospecimen Collection (Procedure)
Observational (RT, biopsy)
Patients undergo RT on day 1. Patients also undergo tumor punch biopsies and blood sample collection prior to the first fraction and on days 1, 3, and 7.
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Percent change of CD8+ T cells
时间窗: Baseline up to day 8
Will be estimated with corresponding two-sided 80% confidence intervals. Also, marker levels at each time point and unstandardized effect sizes (arithmetic differences from baseline) across time points will be estimated along with 2-sided 80% confidence intervals.
Percent change of CD4+ T cells
时间窗: Baseline up to day 8
Will be estimated with corresponding two-sided 80% confidence intervals. Also, marker levels at each time point and unstandardized effect sizes (arithmetic differences from baseline) across time points will be estimated along with 2-sided 80% confidence intervals.
次要结局
未报告次要终点