Off-Target Effects of Breast Cancer Adjuvant Radiation Therapy on Thymus Function in Young Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells
研究概览
简要总结
Breast cancer treatment sometimes includes radiation to the breast or chest wall. There is a small gland, called the thymus, located in the upper chest that may receive a small amount of the radiation aimed at the breast. The goal of this study is to collect blood samples from young women with breast cancer to study the effect of radiation therapy on the thymus gland.
详细描述
This study includes participants whose plan of care may or may not include radiation therapy.
-
Participants whose plan of care includes radiation therapy will have about three teaspoons of research blood collected at the following time points:
-
Before the start of radiation therapy
-
At the end of radiation therapy
-
About six months after completing radiation therapy
-
Participants whose plan of care does NOT include radiation therapy will have about three teaspoons of research blood collected at the following timepoints:
-
After surgery (up to three months after surgery)
-
About 8 months after the first research blood collection
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 50 undergoing mastectomy or breast-conserving surgery for breast cancer of any subtype at DUMC and associated satellite centers
- •Histologic documentation of breast cancer based on pathology
- •Systemic therapies including hormone therapy, targeted therapy, chemotherapy and immunotherapy as given for breast cancer treatment at the discretion of the treating medical oncologist are allowed and use of such therapies will be documented and included as a covariate
- •Willing and able to provide written informed consent
排除标准
- •Prior history of therapeutic high-dose irradiation of the thorax (e.g. for treatment of lung cancer, head/neck cancer, Hodgkin disease, etc., not just radiological imaging alone)
- •History of thymectomy or treatment with immunosuppressive drugs within the past six months
- •Individuals with rheumatoid arthritis or other autoimmune conditions
- •Individuals with Down's syndrome
- •Male patients
研究组 & 干预措施
Radiation Therapy
Up to 100 Breast cancer patients receiving radiation therapy
干预措施: Blood draw for the laboratory assessment (Procedure)
No Radiation Therapy
Up to 25 Breast cancer patients NOT receiving radiation therapy as control
干预措施: Blood draw for the laboratory assessment (Procedure)
结局指标
主要结局
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells
时间窗: baseline
As measured by quantitative PCR in participants receiving radiotherapy (RT)
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells
时间窗: at the end of RT, about 5 weeks
As measured by quantitative PCR in participants receiving radiotherapy (RT)
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells
时间窗: 6 months post-RT
As measured by quantitative PCR in participants receiving radiotherapy (RT)
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells
时间窗: within 3 months after breast cancer surgery
As measured by quantitative PCR in participants NOT receiving radiotherapy (RT)
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells
时间窗: approximately 8-11 months after breast cancer surgery
As measured by quantitative PCR in participants NOT receiving radiotherapy (RT)
Level of CD4+ recent thymic emigrant (RTE) cells in participant blood samples
时间窗: baseline
As measured by flow cytometry in blood from participants receiving radiotherapy (RT)
Level of CD4+ RTE cells in participant blood samples
时间窗: at the end of RT, about 5 weeks
As measured by flow cytometry in blood from participants receiving radiotherapy (RT)
Level of CD4+ RTE cells in participant blood samples
时间窗: 6 months post RT
As measured by flow cytometry in blood from participants receiving radiotherapy (RT)
Level of CD4+ RTE cells in participant blood samples
时间窗: within 3 months of breast cancer surgery
As measured by flow cytometry in blood from participants NOT receiving radiotherapy (RT)
Level of CD4+ RTE cells in participant blood samples
时间窗: approximately 8-11 months after breast cancer surgery
As measured by flow cytometry in blood from participants NOT receiving radiotherapy (RT)
Effect of adjuvant radiotherapy treatment dose on levels of sjTREC-containing T cells
时间窗: 6 months post RT
using a linear mixed-effect model in participants receiving RT
Effect of adjuvant radiotherapy treatment fractionation on levels of sjTREC-containing T cells
时间窗: 6 months post RT
using a linear mixed-effect model in participants receiving RT
Effect of adjuvant radiotherapy treatment fractionation on levels of CD4+ RTE cells
时间窗: 6 months post RT
using a linear mixed-effect model in participants receiving RT
Effect of adjuvant radiotherapy treatment dose on levels of CD4+ RTE cells
时间窗: 6 months post RT
using a linear mixed-effect model in participants receiving RT
次要结局
未报告次要终点