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Идёт набор NCT05851053

Breast Cancer Long-term Outcomes on Cardiac Functioning: a Longitudinal Study

— Наблюдательное Neoplasm, Breast Heart Failure Cardiotoxicity Ventricular Dysfunction

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: Echocardiography.
Кому может быть актуально
Состояния в реестре: Neoplasm, Breast, Heart Failure, Cardiotoxicity, Ventricular Dysfunction. Базовые параметры: Без ограничений · 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
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Rationale: In addition to surgery, effective breast cancer (BC) treatment typically requires chemotherapy, radiotherapy, or both. However, it is still unclear whether patients with BC are at increased risk of long-term cardiac dysfunction due to the adverse effects of these therapies. In a cross-sectional study in primary care, a comparison on cardiac dysfunction between 350 BC survivors and 350 age- and general practitioner (GP)- matched controls without cancer was made. In that study, BC survivors were at increased risk of mild systolic cardiac dysfunction (left ventricle ejection fraction (LVEF)\< 54%). By contrast, there was no significant difference in an LVEF \< 50% or in diastolic dysfunction. To date it remains uncertain whether the mild or subclinical dysfunction we observed predicts further cardiac deterioration. Consequently, the translation of these results into guidelines for the daily practice of the GP is unclear. Objective: The aim of the here proposed study is to clarify whether cardiac function in survivors of BC should be monitored by GPs, by assessing whether an unselected population of long-term BC survivors is at increased risk of developing cardiac dysfunction, whether in this group at-risk subgroups exists, and what factors are associated with the highest risk. Study design: A new assessment of cardiac function among women included in the BLOC-I study. This produces a longitudinal matched cohort design consisting of two cohorts in primary care. Study population: Survivors of BC, diagnosed ≥11 years ago who received chemotherapy and/or radiotherapy, and a matched reference population with no history of cancer. All participants participated in the Breast cancer Long-term Outcome of Cardiac function (BLOC-I) study. Main study parameters/endpoints: Left ventricular systolic dysfunction. Systolic cardiac dysfunction is defined as a LVEF \<54/50/45%.

Вмешательства

  • Диагностический тест Echocardiography
    During echocardiography, the following parameters will be assessed: * Dimensions * Left ventricle function * Right ventricle function * Valves: Aorta valve and pulmonic valve * Other findings such as: frequency, rhythm, quality

Первичные конечные точки

  • Left ventricular systolic dysfunction [Срок оценки: through study completion (from Ocotober 2022 - December 2024)]
Вторичные конечные точки (4)
  • Clinically used LVEF cut-off points <45% and <50% [Срок оценки: through study completion (from Ocotober 2022 - December 2024)]
  • Course of cardiac function [Срок оценки: through study completion (from Ocotober 2022 - December 2024)]
  • Cardiovascular diseases [Срок оценки: through study completion (from Ocotober 2022 - December 2024)]
  • Symptoms of hearth failure [Срок оценки: through study completion (from Ocotober 2022 - December 2024)]

Критерии участия

Критерии включения

  • Patients who previously took part in de BLOC-I study will be included. These criteria were:
  • females diagnosed with stage I-III BC at least five years ago or local or locoregional recurrence of BC at least five years ago
  • treatment with chemotherapy and/or radiotherapy.

Критерии исключения

  • Patients unfit to travel to the hospital due to severe mental or physical illness, based on assessment by their GP.

Exclusion criteria for the BC survivors in the BLOC-I study were:

  • metastatic disease at the time of BC diagnosis;
  • BC treatment after 80 years of age;
  • history of treatment for other types of cancer.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Нидерланды · 1 центр
  • University Medical Center Groningen — Groningen

Публикации

  • Boerman LM, Maass SWMC, van der Meer P, Gietema JA, Maduro JH, Hummel YM, Berger MY, de Bock GH, Berendsen AJ. Long-term outcome of cardiac function in a population-based cohort of breast cancer survivors: A cross-sectional study. Eur J Cancer. 2017 Aug;81:56-65. doi: 10.1016/j.ejca.2017.05.013. Epub 2017 Jun 8. PMID 28601706

Идентификаторы

NCT: NCT05851053 · 202100903

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗