Health Trials

Radiation Therapy and Thymus Function in Young Women With Breast Cancer

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The study population includes women age 18-50 with breast cancer seen in the Duke Breast Oncology Program

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Blood draw for the laboratory assessment

    Procedure/Surgery

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

Treatment groups

125 Participants
are divided into 2 treatment groups
Group A: Radiation Therapy1 intervention
Group B: No Radiation Therapy1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: