Actively Recruiting

FEMALE
Healthy Volunteers
ID05851053

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

52 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

Researchers are investigating whether women who survived breast cancer at least five years ago and received chemotherapy and/or radiotherapy are at increased risk of long-term heart problems. This study compares cardiac function in these survivors to a similar group of women without cancer, aiming to find if monitoring heart health in breast cancer survivors is needed and to identify those at highest risk. It uses a longitudinal matched cohort design within primary care. The study involves two groups: breast cancer survivors diagnosed at least five years ago who underwent chemotherapy and/or radiotherapy, and an age- and general practitioner-matched group with no cancer history. The main assessment involves echocardiography, which measures heart dimensions, left and right ventricle function, valve status, heart rhythm, and other cardiac parameters. Participants will undergo echocardiography from October 2022 through December 2024 to assess left ventricular systolic dysfunction and other heart function markers. Researchers will track changes in heart function, cardiovascular diseases, and heart failure symptoms during the study. The study is observational and takes place in primary care, focusing on long-term outcomes in breast cancer survivors compared to matched controls.

CONDITIONS

Brief 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 or local/locoregional recurrence at least 5 years ago
  • Received chemotherapy and/or radiotherapy treatment
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
  • Breast cancer treatment after 80 years of age
  • History of treatment for other types of cancer

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 2 years

Participants undergo echocardiography to assess heart dimensions, left and right ventricle function, valve function, and other cardiac parameters.

Periodic visits for echocardiography assessments during the study period

Long-term Monitoring

Duration - Through study completion (from October 2022 to December 2024)

Participants are observed for the course of cardiac function, cardiovascular diseases, and symptoms of heart failure.

Follow-up visits aligned with diagnostic evaluations

Trial Site Locations

Total: 1 location

1

University Medical Center Groningen

Groningen, Netherlands, 9700 AD

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Research Team

D

Daan Brandenbarg, PhD

L

Laurine T van der Wal, MSc

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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Frequently Asked Questions

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Published Research Related To This Trial

Long-term outcome of cardiac function in a population-based cohort of breast cancer survivors: A cross-sectional study.

Liselotte M Boerman, Saskia W M C Maass, Peter van der Meer...

https://pubmed.ncbi.nlm.nih.gov/28601706