RecruitingPhase not listed

Radiation Therapy and Thymus Function in Young Women With Breast Cancer

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how radiation treatment for breast cancer affects the thymus, a small gland in the upper chest. It will collect blood samples from women ages 18 to 50 who are having breast cancer surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women ages 18 to 50 having surgery for any type of breast cancer at DUMC or its nearby centers. Surgery may remove the whole breast or only part of it.
  • Breast cancer confirmed by testing a tissue sample.
  • Other breast cancer treatments are allowed, including hormone therapy, targeted therapy, chemotherapy, and immunotherapy.
  • Willing and able to sign a form agreeing to take part in the study.

Who can't join

  • Past high-dose radiation treatment to the chest. Imaging tests alone do not count.
  • Past surgery to remove the thymus, or use of drugs that weaken the immune system within the past 6 months.
  • Rheumatoid arthritis or another autoimmune condition, where the immune system attacks the body.
  • Down syndrome.
  • Men.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NC