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NCT Number: NCT07725172

Radiation Therapy and Thymus Function in Young Women With Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood draw for the laboratory assessment

Procedure

Blood will be drawn and processed for Peripheral Blood Mononuclear Cells (PBMCs). PBMC biomarkers will be used to assess thymopoiesis .

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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

  12. 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

  13. 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

  14. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Duke Radiation Oncology Clinical Trials

CONTACT

[email protected]

(919 668-3726

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Off-Target Effects of Breast Cancer Adjuvant Radiation Therapy on Thymus Function in Young Women

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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