Меню
Идёт набор NCT02743858

Lymphedema Surveillance Study

— Наблюдательное 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
В протоколе указаны: Bilateral arm measurements, Body mass index (BMI), Quality of Life Questionnaire, Blood draw.
Кому может быть актуально
Состояния в реестре: 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 →

Официальное название

A Prospective Surveillance Program for Assessment and Treatment of Breast Cancer-Related Lymphedema After Axillary Lymph Node Dissection

Обзор

This study is being done to find out how many women develop lymphedema after an axillary lymph node dissection. The investigators also want to look for reasons why some women get lymphedema and others don't. Specifically, the investigators want to do tests on the breast tissue that is removed at the time of surgery to see if they can identify inflammation in the breast tissue, which may increase a woman's risk for lymphedema. The investigators will also ask the patient to answer questions to see how much their quality of life is affected by lymphedema, and whether this study can help women by detecting lymphedema earlier.

Вмешательства

  • Другое Bilateral arm measurements
    Pts treated with ALND, bilateral arm measurements will be obtained using the Perometer (Model 350 NT Perometer, Per-System) circumferential arm measurements with elastic tape taken at 4-cm intervals from the wrist to the shoulder \& the L-Dex U400 (Impedimed, Brisbane, Australia) for bioimpedance measurements. Measurements will be performed before surgery, post-operatively \& at timepoints of 6,12,18, \& 24 months after surgery for 2 years will be obtained using the Perometer (Model 350 NT Perom
  • Другое Body mass index (BMI)
    Height and weight will be obtained for each patient at baseline and at each scheduled visit for the purpose of calculating BMI. BMI will be correlated with the presence of inflammatory biomarkers in the tissue, as well as with lymphedema development.
  • Поведенческое Quality of Life Questionnaire
  • Другое Blood draw
    Patients enrolled in the translational study (Cohort 3) will undergo blood draws for serum collection preoperatively and 12-24 months postoperatively to test for FGF2, IL4, IL10, TGFB, Leptin, IL6, and CRP. At both timepoints, up to 20 mL of blood will be collected.

Первичные конечные точки

  • number of incidences of lymphedema [Срок оценки: 2 year]

Критерии участия

Критерии включения

  • Female breast cancer patients over the age of 18
  • Patients consenting for unilateral axillary lymph node dissection (ALND) (prior history of sentinel lymph node biopsy allowed if <6 months from consent)
  • Patients consenting for unilateral sentinel lymph node biopsy (SLNB) and possible ALND are eligible for initial entry into the study, but will become ineligible if ALND is not performed
  • Initially consented patients, treated with SLNB alone, who were originally considered ineligible to continue on study, will be approached for re-enrollment
  • Patients who self-identify as Black or White consenting for unilateral ALND or possible ALND will be approached for enrollment onto translational study (Cohort 3)

Критерии исключения

  • Male breast cancer patients
  • Patients consenting for bilateral axillary surgery
  • Patients with prior history of surgical excision of one or more axillary lymph nodes or SLNB, performed >6 months from date of consent
  • Patients with prior history of ALND
  • Patients with no breast surgery performed at MSK

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 · 7 центров
  • Memorial Sloan Kettering Basking Ridge (Consent only) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Consent only) — Middletown
  • Memorial Sloan Kettering Bergen (Consent only) — Montvale
  • Memorial Sloan Kettering Commack (Consent only) — Commack
  • Memorial Sloan Kettering Westchester (Consent only) — Harrison
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Nassau (Consent only) — Uniondale

Идентификаторы

NCT: NCT02743858 · 16-220

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗