Neoplasm, BreastBLOC-IINCT05851053
Breast Cancer Long-term Outcomes on Cardiac Functioning: a Longitudinal Study
An observational study of Neoplasm, Breast and Heart Failure, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neoplasm, Breast, Heart Failure, Cardiotoxicity
- What is being tested?
- Echocardiography
- How many people
- 455 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9700 AD
Laurine T van der Wal, MSc, 0031503616154, l.t.van.der.wal@umcg.nl
Daan Brandenbarg, PhD
About this study
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.
Read more
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%.
- Being tested
- Echocardiography
- Keywords
- Breast cancer, Cardiotoxicity, Heart failure
- Medical subject headings
- Breast Neoplasms, Heart Failure, Cardiotoxicity, Ventricular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer survivors | Survivors of BC, diagnosed ≥11 years ago, who received chemotherapy and/or radiotherapy Receives: Diagnostic Test: Echocardiography | |
| Reference population | Age and GP matched reference population without a history of cancer Receives: Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular systolic dysfunction
Prevalance of systolic cardiac dysfunction defined as a LVEF <54%
Measured: through study completion (from Ocotober 2022 - December 2024)
Secondary outcomes (4)
Clinically used LVEF cut-off points <45% and <50%
Prevalance of systolic cardiac dysfunction defined as a LVEF <45% and <50%
Measured: through study completion (from Ocotober 2022 - December 2024)
Course of cardiac function
Rate of change of systolic and diastolic cardiac function by change in LVEF
Measured: through study completion (from Ocotober 2022 - December 2024)
Cardiovascular diseases
Prevalence of cardiovascular diseases obtained from electronic patient records
Measured: through study completion (from Ocotober 2022 - December 2024)
Symptoms of hearth failure
Clinical symptoms of heart failure measured using a self-constructed questionnaire
Measured: through study completion (from Ocotober 2022 - December 2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Sep 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasm, BreastStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 455 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851053
- Sponsor's protocol ID
- 202100903
- Acronym
- BLOC-II
- Status last verified
- May 2024
- First submitted
- 14 Nov 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Boerman LM, Maass SWMC, van der Meer P, Gietema JA, Maduro JH, Hummel YM, Berger MY, de Bock GH, Berendsen AJ. Long-term outcome of cardiac function in a population-based cohort of breast cancer survivors: A cross-sectional study. Eur J Cancer. 2017 Aug;81:56-65. doi: 10.1016/j.ejca.2017.05.013. Epub 2017 Jun 8.
PubMed 28601706
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Long-term Outcomes on Cardiac Functioning: a Longitudinal Study
- ClinicalTrials.gov ID
- NCT05851053
- Acronym / sponsor ID
- BLOC-II / 202100903
- Keywords
- Breast cancer, Cardiotoxicity, Heart failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 455 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer survivors | – | Diagnostic Test: EchocardiographySurvivors of BC, diagnosed ≥11 years ago, who received chemotherapy and/or radiotherapy |
| Reference population | – | Diagnostic Test: EchocardiographyAge and GP matched reference population without a history of cancer |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Patients unfit to travel to the hospital due to severe mental or physical illness, based on assessment by their GP.
- metastatic disease at the time of BC diagnosis;
- BC treatment after 80 years of age;
- history of treatment for other types of cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyDuring 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 | Diagnostic test | Breast cancer survivors, Reference population |
Primary outcome
Left ventricular systolic dysfunction
Time frame: through study completion (from Ocotober 2022 - December 2024)
Prevalance of systolic cardiac dysfunction defined as a LVEF <54%
4 secondary outcomes
Clinically used LVEF cut-off points <45% and <50%
Time frame: through study completion (from Ocotober 2022 - December 2024)
Course of cardiac function
Time frame: through study completion (from Ocotober 2022 - December 2024)
Cardiovascular diseases
Time frame: through study completion (from Ocotober 2022 - December 2024)
Symptoms of hearth failure
Time frame: through study completion (from Ocotober 2022 - December 2024)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Background: PubMed 28601706Boerman LM, Maass SWMC, van der Meer P, Gietema JA, Maduro JH, Hummel YM, Berger MY, de Bock GH, Berendsen AJ. Long-term outcome of cardiac function in a population-based cohort of breast cancer survivors: A cross-sectional study. Eur J Cancer. 2017 Aug;81:56-65. doi: 10.1016/j.ejca.2017.05.013. Epub 2017 Jun 8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasm, Breast and Heart Failure, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daan Brandenbarg, PhD (0031628475305, d.brandenbarg@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular systolic dysfunction (time frame: through study completion (from Ocotober 2022 - December 2024)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05851053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.