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临床试验/NCT01904331
NCT01904331已完成不适用

Study of the Cardiovascular and Psychosocial Effects of the Treatment of Breast Cancer With Chemotherapy and/or Radiotherapy

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
700
试验地点
1
主要终点
Cardiac dysfunction

研究概览

简要总结

The purpose of this study is to assess the prevalence of cardiac dysfunction and (undiagnosed) heart failure in women registered in general practice with a history of breast cancer who received chemotherapy and / or radiotherapy as compared to a matched female control population.

详细描述

Background:

Due to screening and progress in treatment the overall survival of women treated for breast cancer has increased over the last decades. Therefore, the long-term effects of breast cancer have emerged as an important topic. An increased mortality is seen within years post treatment due to an increased incidence of cardiac dysfunction among survivors of breast cancer. This increased mortality is related to long term side effects of treatment with chemotherapy and radiotherapy. Earlier studies into this topic have focused on specific patient groups and therefore these results are difficult to translate to the general population. Furthermore, most echo graphic studies have focused on the systolic dysfunction of the heart, which is a late stage of the cardiac deterioration. Detecting cardiotoxicity early on provides the opportunity for early treatment and might therewith prevent deterioration of cardiac function and improve the prognosis of patients

Objectives:

Primary objective

  1. To assess the risk of a systolic and / or diastolic cardiac dysfunction at echocardiography of breast cancer patients compared to matched controls.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • For breast cancer patients: minimum of 5 years after treatment for breast cancer with chemo- and/or radiotherapy and after 1970
  • For breast cancer patients: younger than 80 at the time of diagnosis of breast cancer
  • willing to sign an informed consent
  • older than 18 at the time of inclusion

排除标准

  • Treatment with chemo- and/or radiotherapy for other types of cancer besides breast cancer
  • women who are unable to participate (e.g. terminally or mentally ill)

结局指标

主要结局

Cardiac dysfunction

时间窗: on average 11 years after treatment with breast cancer

systolic and diastolic parameters at time of inclusion

次要结局

  • Biomarkers +DNA(on average 11 years after treatment with breast cancer)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. A.J. Berendsen

Dr.

University Medical Center Groningen

研究点 (1)

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