NCT07725172 · Duke University
Radiation Therapy and Thymus Function in Young Women With Breast Cancer
What this study is about
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.
View original scientific description
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.
Interventions
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 .
Primary outcome measures
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline
As measured by flow cytometry in blood from participants receiving radiotherapy (RT)
Level of CD4+ RTE cells in participant blood samples
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months post RT
using a linear mixed-effect model in participants receiving RT
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Durham, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 29, 2026 · Source of record for eligibility and locations