Recruiting

Radiation Therapy

Sponsor:

Duke University

Code:

NCT07725172

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Blood draw for the laboratory assessment

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Study ID

NCT07725172

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Arms

Radiation Therapy

Up to 100 Breast cancer patients receiving radiation therapy

No Radiation Therapy

Up to 25 Breast cancer patients NOT receiving radiation therapy as control

Interventions

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 measure

  • Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells [ Time Frame: baseline ]
  • 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 ]
  • Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells [ Time Frame: 6 months post-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 ]
  • 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 ]
  • Level of CD4+ recent thymic emigrant (RTE) cells in participant blood samples [ Time Frame: baseline ]
  • Level of CD4+ RTE cells in participant blood samples [ Time Frame: at the end of RT, about 5 weeks ]
  • Level of CD4+ RTE cells in participant blood samples [ Time Frame: 6 months post RT ]
  • Level of CD4+ RTE cells in participant blood samples [ Time Frame: within 3 months of breast cancer surgery ]
  • Level of CD4+ RTE cells in participant blood samples [ Time Frame: approximately 8-11 months after breast cancer surgery ]
  • Effect of adjuvant radiotherapy treatment dose on levels of sjTREC-containing T cells [ Time Frame: 6 months post RT ]
  • Effect of adjuvant radiotherapy treatment fractionation on levels of sjTREC-containing T cells [ Time Frame: 6 months post RT ]
  • Effect of adjuvant radiotherapy treatment fractionation on levels of CD4+ RTE cells [ Time Frame: 6 months post RT ]
  • Effect of adjuvant radiotherapy treatment dose on levels of CD4+ RTE cells [ Time Frame: 6 months post RT ]

Central Contacts and Locations

Central contacts

Duke Radiation Oncology Clinical Trials

(919 668-3726RadOnc-Clinical_Trials@dm.duke.edu

Locations

Duke Cancer Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Eileen Duffy, RN OCN

919-668-3726eileen.duffy@duke.edu

Linda Kaltenbach, PhD

(919) 668-3726Linda.Kaltenbach@duke.edu

Principal Investigator:

Susan McDuff, MD PhD

More Information

Sponsor

Duke University

Last update posted

Sep 29, 2026

Last verified

Sep, 2026

Keywords

  • breast cancer in young women
  • blood collection
  • thymopoesis
  • thymus
  • radiation therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Duke University on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.