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Trial Title:
Breast Cancer Long-term Outcomes on Cardiac Functioning: a Longitudinal Study
NCT ID:
NCT05851053
Condition:
Neoplasm, Breast
Heart Failure
Cardiotoxicity
Ventricular Dysfunction
Conditions: Official terms:
Breast Neoplasms
Heart Failure
Ventricular Dysfunction
Cardiotoxicity
Conditions: Keywords:
Breast cancer
Cardiotoxicity
Heart failure
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Echocardiography
Description:
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
Arm group label:
Breast cancer survivors
Arm group label:
Reference population
Summary:
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%.
Criteria for eligibility:
Study pop:
BC survivors were matched with women of the same age (±1 year) who had the same GP, but
who had no history of cancer or cancer treatment (chemotherapy or radiotherapy).
A longitudinal matched cohort design consisting of two cohorts in primary care: one with
survivors of BC, diagnosed ≥11 years ago who received chemotherapy and/or radiotherapy,
and one with a matched reference population with no history of cancer.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University Medical Center Groningen
Address:
City:
Groningen
Zip:
9700 AD
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Laurine T van der Wal, MSc
Phone:
0031503616154
Email:
l.t.van.der.wal@umcg.nl
Investigator:
Last name:
Daan Brandenbarg, PhD
Email:
Principal Investigator
Investigator:
Last name:
Laurine T van der Wal, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Saskia WMC Maass, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Jourik A Gietema, Prof. dr.
Email:
Principal Investigator
Investigator:
Last name:
Peter van der Meer, Prof. dr.
Email:
Principal Investigator
Investigator:
Last name:
Geertruida H de Bock, Prof. dr.
Email:
Principal Investigator
Investigator:
Last name:
Marjolein Y Berger, Prof. dr.
Email:
Principal Investigator
Investigator:
Last name:
Anne PG Crijns, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Michiel R de Boer, PhD
Email:
Sub-Investigator
Start date:
September 1, 2022
Completion date:
December 31, 2026
Lead sponsor:
Agency:
University Medical Center Groningen
Agency class:
Other
Collaborator:
Agency:
ZonMw: The Netherlands Organisation for Health Research and Development
Agency class:
Other
Source:
University Medical Center Groningen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05851053
