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Идёт набор NCT03790943

Cardiac Dysfunction in Childhood Cancer Survivors

— Наблюдательное Cardiac Dysfunction Cardiovascular Diseases Childhood Cancer

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: cardiac assessment.
Кому может быть актуально
Состояния в реестре: Cardiac Dysfunction, Cardiovascular Diseases, Childhood Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
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

Prospective Single Center Cohort Study for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors

Обзор

This multicenter, prospective cohort study evaluates early cardiac dysfunction in adult survivors of childhood cancer. The hypothesis of this study is that cardiac dysfunction can be detected earlier when using speckle tracking echocardiography as novel echocardiographic technique compared to conventional echocardiography.

Подробное описание

Cardiovascular disease including cardiac dysfunction is the leading non-malignant cause of death in childhood cancer survivors. Early detection of cardiac dysfunction is important to identify those in need for medical intervention to improve outcome. This study invites adult childhood cancer survivors to a clinical appointment to the University Hospital Bern, Switzerland. A detailed, standardized cardiac assessment including conventional and novel echocardiographic techniques (speckle tracking) as well as cardiopulmonary exercise testing is performed. Cardiac dysfunction is evaluated in survivors who have had cardiotoxic cancer therapy with anthracyclines and/or chest radiation (high risk) and in survivors who have had chemotherapy other than anthracyclines (standard risk).

Вмешательства

  • Диагностический тест cardiac assessment
    Personal history, physical examination including anthropometry with hip/waist-ratio, electrocardiogram, echocardiography, 1-minute-sit-to-stand test, questionnaires on health-related quality of life (SF-36), diet, physical activity, and fatigue

Первичные конечные точки

  • Prevalence of cardiac dysfunction [Срок оценки: Baseline and longitudinal follow-up where clinically indicated]
  • Prevalence of cardiac dysfunction [Срок оценки: Baseline and longitudinal follow-up where clinically indicated]
  • Prevalence of impaired exercise capacity [Срок оценки: Baseline]
  • Treatment-related risk factors [Срок оценки: Baseline]
  • Treatment-related risk factors [Срок оценки: Baseline]

Критерии участия

This prospective cohort study is nested within the Childhood Cancer Registry (ChCR), a national, population-based cancer registry that includes all children and adolescents in Switzerland who were diagnosed with cancer at age 0-20 years. It includes patients diagnosed with leukemia, lymphoma, central nervous system tumors, and malignant solid tumours or Langerhans cell histiocytosis. Childhood cancer survivors have survived at least 5 years from cancer diagnosis.

Критерии включения

  • Registered in the ChCR
  • Formerly treated at the Department of Pediatric Hematology/Oncology of one of five participating centers
  • Treated with any chemotherapy and/or chest radiation
  • Survived ≥ 5 years since most recent cancer diagnosis (primary cancer, relapse(s), secondary cancer) at time of examination
  • Diagnosed at age ≤ 20 years
  • ≥ 18 years of age at time of study participation
  • Resident in Switzerland
  • Written informed consent

Критерии исключения

  • Study participants will be excluded if they do not meet the above mentioned inclusion criteria or refuse to participate in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 6 центров
  • Department of Cardiology, University Hospital Basel — Basel
  • Institute of Social and Preventive Medicine, University of Bern — Bern
  • Department of Cardiology, Inselspital Bern — Bern
  • Department of Cardiology, University Hospitals of Geneva — Geneva
  • Department of Cardiology, Lucerne Cantonal Hospital — Lucerne
  • Department of Cardiology, Cantonal Hospital of St. Gallen — Sankt Gallen

Публикации

  • Schindera C, Kuehni CE, Pavlovic M, Haegler-Laube ES, Rhyner D, Waespe N, Roessler J, Suter T, von der Weid NX. Diagnosing Preclinical Cardiac Dysfunction in Swiss Childhood Cancer Survivors: Protocol for a Single-Center Cohort Study. JMIR Res Protoc. 2020 Jun 10;9(6):e17724. doi: 10.2196/17724. PMID 32269016

Идентификаторы

NCT: NCT03790943 · SCCSS_cardiac_FU

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗