An observational study in Breast Cancer, sponsored by Duke University. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Duke University · Observational
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.
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:
Participants whose plan of care does NOT include radiation therapy will have about three teaspoons of research blood collected at the following timepoints:
The study population includes women age 18-50 with breast cancer seen in the Duke Breast Oncology Program
Exclusion Criteria:
Up to 100 Breast cancer patients receiving radiation therapy
Procedure: Blood draw for the laboratory assessment
Up to 25 Breast cancer patients NOT receiving radiation therapy as control
Procedure: Blood draw for the laboratory assessment
Blood will be drawn and processed for Peripheral Blood Mononuclear Cells (PBMCs). PBMC biomarkers will be used to assess thymopoiesis .
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells
As measured by quantitative PCR in participants receiving radiotherapy (RT)
Time frame: baseline
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells
As measured by quantitative PCR in participants receiving radiotherapy (RT)
Time frame: at the end of RT, about 5 weeks
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells
As measured by quantitative PCR in participants receiving radiotherapy (RT)
Time frame: 6 months post-RT
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells
As measured by quantitative PCR in participants NOT receiving radiotherapy (RT)
Time frame: within 3 months after breast cancer surgery
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells
As measured by quantitative PCR in participants NOT receiving radiotherapy (RT)
Time frame: approximately 8-11 months after breast cancer surgery
Level of CD4+ recent thymic emigrant (RTE) cells in participant blood samples
As measured by flow cytometry in blood from participants receiving radiotherapy (RT)
Time frame: baseline
Level of CD4+ RTE cells in participant blood samples
As measured by flow cytometry in blood from participants receiving radiotherapy (RT)
Time frame: at the end of RT, about 5 weeks
Level of CD4+ RTE cells in participant blood samples
As measured by flow cytometry in blood from participants receiving radiotherapy (RT)
Time frame: 6 months post RT
Level of CD4+ RTE cells in participant blood samples
As measured by flow cytometry in blood from participants NOT receiving radiotherapy (RT)
Time frame: within 3 months of breast cancer surgery
Level of CD4+ RTE cells in participant blood samples
As measured by flow cytometry in blood from participants NOT receiving radiotherapy (RT)
Time frame: approximately 8-11 months after breast cancer surgery
Effect of adjuvant radiotherapy treatment dose on levels of sjTREC-containing T cells
using a linear mixed-effect model in participants receiving RT
Time frame: 6 months post RT
Effect of adjuvant radiotherapy treatment fractionation on levels of sjTREC-containing T cells
using a linear mixed-effect model in participants receiving RT
Time frame: 6 months post RT
Effect of adjuvant radiotherapy treatment fractionation on levels of CD4+ RTE cells
using a linear mixed-effect model in participants receiving RT
Time frame: 6 months post RT
Effect of adjuvant radiotherapy treatment dose on levels of CD4+ RTE cells
using a linear mixed-effect model in participants receiving RT
Time frame: 6 months post RT
Plan to share: Undecided — IPD may be shared after publication if deidentified.
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