Меню
Идёт набор NCT05032768

The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients

Наблюдательное Radiation Dermatitis Skin Microbiome Breast Cancer Reconstructive Surgery

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: post-operative radiotherapy.
Кому может быть актуально
Состояния в реестре: Radiation Dermatitis, Skin Microbiome, Breast Cancer, Reconstructive Surgery. Базовые параметры: 18 лет — 70 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients Receiving Radiation After Mastectomy and Reconstructive Surgery

Обзор

The breast cancer patients who received radiotherapy after mastectomy and breast reconstruction will be enrolled. The skin microbiome before radiotherapy and its changes after radiotherapy will be analyzed systematically to find out whether the skin microbiome is associated with the severity of radiation dermatitis.

Подробное описание

Radiotherapy is an important treatment for breast cancer patients. About 95% of patients receiving radiotherapy will develop a degree of radiation dermatitis. Radiation dermatitis is usually limited to the site of radiation treatment. Symptoms vary and can range from itching, burning and pain to open or bleeding ulcers, which can greatly affect the quality of life of patients. Severe acute radiation dermatitis can lead to interruption or delay of treatment. At present, there is no standard for the prevention and treatment of radiation dermatitis. Our skin is home to millions of bacteria, fungi and viruses which compose the skin microbiota. Skin microbiota interacts with skin and affects physiology and immunity of the skin. Previous studies have reported the effects of radiotherapy on skin and immune system. However, so far, no studies have analyzed the effects of radiotherapy on skin microbiome and how skin microbiome affects the skin immune responses after radiotherapy. In this study, the breast cancer patients who received radiotherapy after mastectomy and breast reconstruction will be enrolled. The skin microbiome before radiotherapy and its changes after radiotherapy will be analyzed systematically to find out whether the skin microbiome is associated with the severity of radiation dermatitis. The long-term goal of this study is to deepen the understanding of the role of skin microbiome in the occurrence and development of radiation dermatitis, and provide a basis for subsequent exploration to reduce radiation dermatitis by regulating skin microecology.

Вмешательства

  • Лучевая терапия post-operative radiotherapy
    Breast cancer patients who have received reconstructive surgery will receive post-operative radiotherapy.

Первичные конечные точки

  • Skin microbiome differences between patients with and without >=2 acute radiation dermatitis [Срок оценки: 3 months]
Вторичные конечные точки (1)
  • Skin microbiome differences between patients with and without >=2 late radiation dermatitis [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • Female patients
  • Invasive breast cancer confirmed by pathology
  • Underwent mastectomy and breast reconstruction
  • Radiotherapy after breast reconstruction
  • ECOG score 0-1
  • Signed informed consent

Критерии исключения

  • Previous breast or chest radiotherapy
  • Other serious skin diseases (systemic lupus erythematosus, skin sclerosis, et al) and cannot receive radiotherapy
  • Pregnant women
  • Patients who are unwilling or unable to receive regular follow-up.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT05032768 · FDRT-BC015

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗