Radiation Therapy and Thymus Function in Young Women With Breast Cancer

This study is looking at how radiation therapy for breast cancer might affect a small gland in your chest called the thymus. The thymus plays a role in your immune system. Researchers will collect blood samples from young women (ages 18-50) with breast cancer who are having surgery, whether or not they receive radiation therapy. They will measure specific markers in your blood called sjTREC (signal joint T cell Receptor Exclusion Circles) at different times to see if radiation therapy changes them. This study aims to understand the impact of radiation on the thymus. The study plans to enroll 125 participants.

Study design: This is an observational study involving 125 young women with breast cancer. It is not testing a new treatment, but rather observing the effects of standard care.
What's involved: You would have about three teaspoons of blood drawn at specific times: before, during, and after radiation therapy, or after surgery and then about 8 months later if you don't receive radiation.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for about six months after completing radiation therapy, or about 8 months after the first blood collection if not receiving radiation.

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Radiation Therapy and Thymus Function in Young Women With Breast Cancer

Not Yet Recruiting

Not specifiedAges 18–50Observational

Duke University

~125 participants

Updated 2026-07-24 on ClinicalTrials.gov

What's tested:Blood draw for the laboratory assessment

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells

Measured over baseline

+13 more outcomes measured

Conditions

Breast Cancer

Where it's being run

1 sites across 1 states

North Carolina1

Study leadership

Susan McDuff, MD PhD · PRINCIPAL_INVESTIGATOR · Duke University Health System (DUHS)
Andrew Macintyre, PhD · PRINCIPAL_INVESTIGATOR · Duke Human Vaccine Institute

Who to contact

Duke Radiation Oncology Clinical Trials

[email protected]

(919 668-3726

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cellsbaseline
As measured by quantitative PCR in participants receiving radiotherapy (RT)
Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cellsat 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 cells6 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 cellswithin 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 cellsapproximately 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 samplesbaseline
As measured by flow cytometry in blood from participants receiving radiotherapy (RT)
Level of CD4+ RTE cells in participant blood samplesat 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 samples6 months post RT
As measured by flow cytometry in blood from participants receiving radiotherapy (RT)
Level of CD4+ RTE cells in participant blood sampleswithin 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 samplesapproximately 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 cells6 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 cells6 months post RT
using a linear mixed-effect model in participants receiving RT
Effect of adjuvant radiotherapy treatment fractionation on levels of CD4+ RTE cells6 months post RT
using a linear mixed-effect model in participants receiving RT
Effect of adjuvant radiotherapy treatment dose on levels of CD4+ RTE cells6 months post RT
using a linear mixed-effect model in participants receiving RT

Trialytics