Radiation Therapy and Thymus Function in Young Women With Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood draw for the laboratory assessment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Off-Target Effects of Breast Cancer Adjuvant Radiation Therapy on Thymus Function in Young Women
Overview
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
- Procedure 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 measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Duke Cancer Center — Durham
Identifiers
NCT: NCT07725172 · Pro00120784 · BC250719P1