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Набор скоро начнётся NCT07725172

Radiation Therapy and Thymus Function in Young Women With Breast Cancer

— Наблюдательное Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Blood draw for the laboratory assessment.
Кому может быть актуально
Состояния в реестре: Breast Cancer. Базовые параметры: 18 лет — 50 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

  • Процедура 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 .

Первичные конечные точки

  • Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells [Срок оценки: baseline]
  • Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells [Срок оценки: at the end of RT, about 5 weeks]
  • Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells [Срок оценки: 6 months post-RT]
  • Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells [Срок оценки: within 3 months after breast cancer surgery]
  • Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells [Срок оценки: approximately 8-11 months after breast cancer surgery]
  • Level of CD4+ recent thymic emigrant (RTE) cells in participant blood samples [Срок оценки: baseline]
  • Level of CD4+ RTE cells in participant blood samples [Срок оценки: at the end of RT, about 5 weeks]
  • Level of CD4+ RTE cells in participant blood samples [Срок оценки: 6 months post RT]
  • Level of CD4+ RTE cells in participant blood samples [Срок оценки: within 3 months of breast cancer surgery]
  • Level of CD4+ RTE cells in participant blood samples [Срок оценки: approximately 8-11 months after breast cancer surgery]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 1 центр
  • Duke Cancer Center — Durham

Идентификаторы

NCT: NCT07725172 · Pro00120784 · BC250719P1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗