Actively Recruiting

FEMALE
Healthy Volunteers
NCT05851053

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

Led by University Medical Center Groningen · Updated on 2024-05-29

455

Participants Needed

1

Research Sites

226 weeks

Total Duration

On this page

Sponsors

U

University Medical Center Groningen

Lead Sponsor

Z

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborating Sponsor

AI-Summary

What this Trial Is About

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%.

CONDITIONS

Official Title

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

Who Can Participate

FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients who participated in the BLOC-I study
  • Diagnosed with stage I-III breast cancer at least five years ago or had local or locoregional recurrence at least five years ago
  • Received treatment with chemotherapy and/or radiotherapy
Not Eligible

You will not qualify if you...

  • Unable to travel to the hospital due to severe mental or physical illness as assessed by their GP
  • Metastatic disease at the time of breast cancer diagnosis
  • Received breast cancer treatment after age 80
  • History of treatment for other types of cancer

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Trial Site Locations

Total: 1 location

1

University Medical Center Groningen

Groningen, Netherlands, 9700 AD

Actively Recruiting

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Research Team

D

Daan Brandenbarg, PhD

CONTACT

L

Laurine T van der Wal, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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