Breast Cancer
Conditions
Keywords
breast cancer in young women, blood collection, thymopoesis, thymus, radiation therapy
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.
Detailed description
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
Interventions
Blood will be drawn and processed for Peripheral Blood Mononuclear Cells (PBMCs). PBMC biomarkers will be used to assess thymopoiesis .
Sponsors
Duke University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells | baseline | As measured by quantitative PCR in participants receiving radiotherapy (RT) |
| Level of CD4+ recent thymic emigrant (RTE) cells in participant blood samples | baseline | As measured by flow cytometry in blood from participants receiving radiotherapy (RT) |
| Level of CD4+ RTE cells in participant blood samples | at the end of RT, about 5 weeks | As measured by flow cytometry in blood from participants receiving radiotherapy (RT) |
| Effect of adjuvant radiotherapy treatment dose on levels of sjTREC-containing T cells | 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 | 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 | 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 | 6 months post RT | using a linear mixed-effect model in participants receiving RT |
Countries
United States
Contacts
CONTACTDuke Radiation Oncology Clinical Trials
PRINCIPAL_INVESTIGATORSusan McDuff, MD PhD
Duke University Health System (DUHS)
PRINCIPAL_INVESTIGATORAndrew Macintyre, PhD
Duke Human Vaccine Institute
Outcome results
None listed