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Идёт набор NCT06180642

Reliability and Validity of Ultrasound for the Assessment of Soft Tissue Properties After Breast Cancer Treatment

— Наблюдательное Breast Neoplasms

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: Assessment of soft tissue properties, Retest assessment of soft tissue properties.
Кому может быть актуально
Состояния в реестре: Breast Neoplasms. Базовые параметры: от 18 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
Бельгия
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

Reliability and Validity of Ultrasound for the Assessment of Structural and Mechanical Properties of Soft Tissues at the Upper Limb Region in Women After Breast Cancer Treatment

Обзор

After 1 year, more than 50% experience upper limb (UL) complaints after treatment for breast cancer. These complaints are disabling and cause limitations in daily life and this leads to a decrease in the patient's quality of life. The cause of these UL complaints is complex and multifactorial. Due to breast cancer treatment, the structural (tissue composition and volume) and mechanical (tissue stiffness) properties of the soft tissue may change. These changes can occur in the muscle, skin and surrounding fascia and especially in the soft tissue around the breast and axilla where that treatment is localised. Ultrasound with specific 'add-on' techniques can objectively assess these features and provide a picture of their role in UL function after breast cancer. The first aim in this study is to investigate the reliability and validity of conventional 2D ultrasound for 1) soft tissue composition and 2) soft tissue thickness at the level of the breast and upper limb. The reliability and validity of shear wave elastography, a specific complement to conventional 2D ultrasound, to assess tissue stiffness will also be examined.

Вмешательства

  • Другое Assessment of soft tissue properties
    Assessment of soft tissue properties at the upper limb region with clinical assessments and ultrasound
  • Другое Retest assessment of soft tissue properties
    Retest Assessment of soft tissue properties at the upper limb region with clinical assessments and ultrasound

Первичные конечные точки

  • Reliability of soft tissue thickness (mm) [Срок оценки: 1 week]
  • Reliability of soft tissue composition [Срок оценки: 1 week]
  • Reliability of soft tissue elasticity (m/sec) [Срок оценки: 1 week]
Вторичные конечные точки (1)
  • Validity of soft tissue elasticity [Срок оценки: 1 week]

Критерии участия

  • Breast cancer patients without upper limb dysfunctions (n=30) Inclusion Criteria
  • Patients with unilateral primary breast cancer
  • Surgery including, either: Mastectomy with axillary lymph node dissection or sentinel lymph node biopsy or breast conserving surgery with axillary lymph node dissection or sentinel lymph node biopsy
  • At least 3 months after surgery or radiotherapy in order to take into account wound healing
  • Comprehensive of the Dutch language
  • QuickDASH score <15/100

Критерии исключения

  • Bilateral surgery, widespread distance metastases, previous breast surgery
  • Diagnosis of neurological or rheumatological condition
  • upper limb dysfunctions caused by other reasons
  • Breast cancer patients with upper limb dysfunctions (n=30) Inclusion Criteria
  • Patients with unilateral primary breast cancer
  • Surgery including, either: Mastectomy with axillary lymph node dissection or sentinel lymph node biopsy or breast conserving surgery with axillary lymph node dissection or sentinel lymph node biopsy
  • At least 3 months after surgery or radiotherapy in order to take into account wound healing
  • Comprehensive of the Dutch language
  • QuickDASH score >15/100

Критерии исключения

  • Bilateral surgery, widespread distance metastases, previous breast surgery
  • Diagnosis of neurological or rheumatological condition
  • upper limb dysfunctions caused by other reasons
  • Healthy volunteers (n=30)

Критерии включения

  • Healthy women (QuickDASH <15) age-matched with a breast cancer patient from the main study
  • Comprehensive of the Dutch language

Критерии исключения

  • upper limb dysfunctions
  • Diagnosis of neurological or rheumatological condition, diabetes

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Бельгия · 1 центр
  • Universiteit Antwerpen — Antwerp

Идентификаторы

NCT: NCT06180642 · 2776

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗