- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01904331
Breast Cancer Long-term Outcome of Cardiac Dysfunction (BLOC)
Study of the Cardiovascular and Psychosocial Effects of the Treatment of Breast Cancer With Chemotherapy and/or Radiotherapy
Study Overview
Status
Conditions
Detailed Description
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
To assess the risk of a systolic and / or diastolic cardiac dysfunction at echocardiography of breast cancer patients compared to matched controls.
Secondary objective:
- To assess the risk of heart failure( a combination of clinical complaints, objective measures at physical examination, laboratory examination or echocardiography) in breast cancer patients as compared to matched controls
- To determine the value of patient characteristics, clinical complaints and signs in physical examination in diagnosing cardiac dysfunction as found of echocardiography
- To determine the additional diagnostic value of biomarkers; N-terminal pro-hormone of brain natriuretic peptide (NT-pro-BNP) and high sensitive troponin T (hs-troponinT) in diagnosing cardiac dysfunction, as found on echocardiography
- Genetic analysis
Study design and population:
This is a cross-sectional, observational study in women in general practice who have been curatively treated for breast cancer with chemo and / or radiotherapy at a minimum of 5 years ago and an age and general practitioner (GP) matched female control population. Patients must be 18 years or older, younger than 80 at the time of diagnosis, not been treated for other types of cancer with chemo- and/or radiotherapy and must be willing to give written informed consent Primary study parameters
- Systolic and diastolic cardiac function of echocardiography
- Hospital Anxiety and Depression Scale (HADS)
- Multi dimensional Fatigue Inventory (MFI-20)
- Cardiovascular Risk Management (CVRM)
- Short physical examination: blood pressure, height, weight, waist circumference, electrocardiography, signs of edema, auscultation
- Laboratory testing: Hemoglobin, hematocrit, leucocytes, creatinine , estimated glomerular filtration rate (GFR), cholesterol, triglycerides, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Cholesterol/HDL ratio, C-reactive protein (CRP),Thyroid stimulating hormone (TSH), glucose
- Serum and plasma for biomarkers
- ethylenediaminetetraacetic acid (EDTA) -tube for DeoxyriboNucleic Acid (DNA) analysis Outcomes
Primary outcome:
The cardiac dysfunction will be related to type of therapy and compared to the age-and general practice matched control group. Information on type of therapy will be gathered trough contacting the hospitals were patients were treated.
Secondary outcome:
Symptoms and signs of women with cardiac dysfunction will be compared with those without cardiac dysfunction. A comparison between women treated for breast cancer and women without breast cancer will be made.
The level of the biomarkers will be linked with the cardiac dysfunction. In women treated for breast cancer with chemo- and/or radiotherapy these will also be linked with type of therapy.
DNA analysis will be carried out to investigate if changes in candidate genes are related to the development of cardiac dysfunction.
Burden and risks associated with participation, benefit and group relatedness The minimal invasive tests will be performed if patient are willing to participate in de study after contact trough letters. As far as known no serious adverse events are linked to the described study procedures.
With this study we hope to get insight in the risk of cardiac dysfunction after chemo- and/or radiotherapy in women treated for breast cancer. And to determine possibly diagnostic measure to detect this deterioration. Eventually, this may contribute to the early detection of cardiac dysfunction in women treated with chemo- and/or radiotherapy for breast cancer to improve the prognosis for patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Groningen, Netherlands, 9700RB
- University Medical Center Groningen (UMCG)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
All patients are selected in primary care practices in the Northern part of the Netherlands.
Controls are randomly selected in the same primary care clinics as participants.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Breast cancer patients
Women who were curatively treated with chemo- and/or radiotherapy for breast cancer
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Controls
Women matched on age and general practitioner with the breast cancer patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac dysfunction
Time Frame: on average 11 years after treatment with breast cancer
|
systolic and diastolic parameters at time of inclusion
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on average 11 years after treatment with breast cancer
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biomarkers +DNA
Time Frame: on average 11 years after treatment with breast cancer
|
Plasma EDTA, lithium-heparin plasma and serum are stored at -80 freezer at the the time of inclusion.
Determination of biomarkers will take place at the end of the study period Whole blood is frozen for DNA analysis at time of inclusion.
|
on average 11 years after treatment with breast cancer
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical complaints and signs at inclusion
Time Frame: on average 11 years after treatment with breast cancer
|
Questionnaires (CVRM, HADS and MFI-20), a short physical examination and a electrocardiography at time of inclusion
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on average 11 years after treatment with breast cancer
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Collaborators and Investigators
Investigators
- Study Director: Marjolein Y Berger, M.D. Ph.D., University Medical Center Groningen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 686317
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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