Меню
Набор по приглашению NCT06900023

The BEACON Trial: Diagnostic Tools for Breast Lymphedema After Treatment for Breast Cancer

— Наблюдательное Breast Edema Breast Lymphedema Lymphedema, Breast Cancer Lymphedema

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Breast Edema, Breast Lymphedema, Lymphedema, Breast Cancer, Lymphedema. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The goal of this observational study is to learn if participants agree to take part in the study, if the methods we are using for the study are feasible for the participants and the researchers, and to study how well two tools (tissue dielectric constant and ultrasound) measure breast edema after breast conserving surgery for breast cancer. Participants who agree to be in the study will be asked to come in for one appointment of approximately two hours. All data will be collected during this one visit. Participants will be asked to fill out two questionnaires regarding their symptoms, and one questionnaire regarding their surgical scar. The research staff will conduct a clinical examination, measure breast edema using ultrasound and tissue dielectric constant, measure arm volume with the perometer and fluid with the SOZO, and take photographs of both breasts.

Подробное описание

The goal of this observational study is to learn if the study protocol is feasible, if we can accrue participants easily, and to determine how well two tools (tissue dielectric constant and ultrasound) identify breast edema after breast conserving surgery for breast cancer.

Participants will be asked to attend one appointment in which all data will be collected. This will include questionnaires regarding symptoms, clinical examination, measurement of breast edema using two tools (ultrasound and tissue dielectric constant), measurement with the perometer and SOZO, and clinical photographs.

Первичные конечные точки

  • Tissue Dielectric Constant [Срок оценки: Baseline]
  • Breast Ultrasound [Срок оценки: Baseline]
Вторичные конечные точки (12)
  • Patient-Reported Outcome Measures [Срок оценки: Baseline]
  • Patient-Reported Outcome Measures [Срок оценки: Baseline]
  • Scar Assessment Tool [Срок оценки: Baseline]
  • Clinical Examination of Lymphedema of the Upper Extremity Clinical Exam Tool [Срок оценки: Baseline]
  • Clinical Examination - Pitting Edema [Срок оценки: Baseline]
  • Clinical Examination - Peau d'orange [Срок оценки: Baseline]
  • Clinical Examination - Tissue fibrosis [Срок оценки: Baseline]
  • Clinical Examination - Tenderness to palpation [Срок оценки: Baseline]
  • Clinical Examination - Erythema [Срок оценки: Baseline]
  • Clinical Examination - Scar localization [Срок оценки: Baseline]
  • Clinical Examination - Visual fullness [Срок оценки: Baseline]
  • Clinical Examination - Stemmer sign [Срок оценки: Baseline]

Критерии участия

All participants must meet the following inclusion criteria:

  • Be a female between the ages of 18 and 85 years.
  • Have undergone breast conserving surgery +/- LN removal (sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND)
  • Have no residual cancer in the breast after definitive breast surgery
  • Have been treated with radiation therapy and have completed breast cancer treatment (excluding Herceptin and hormonal treatments) at MGH greater than or equal to 3 months ago.
  • Be able to read and understand English
  • Understand the proposed study and be willing and fully able to comply with the study procedures
  • Be a willing participant and be capable of giving and has given informed written consent for entry into the study

Критерии исключения

Participants will be excluded if they:

  • Have bilateral BC
  • Have metastatic or inflammatory BC
  • Will be excluded from the SOZO measurement of the study if they have implanted cardiac devices or neurostimulators
  • Have any medical condition that may result in breast swelling;
  • Uncontrolled congestive cardiac failure,
  • Arteriovenous haemodialysis,
  • Current infection or cellulitis of either breast.
  • Be pregnant or currently breast feeding.
  • Have a known over-active thyroid or known benign thyroid tumour

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT06900023 · 23412

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗