Breast CancerNCT03206333
Automated Quantification of Coronary Artery Calcifications on Radiotherapy Planning CTs for Cardiovascular Risk Prediction in Breast Cancer Patients: the BRAGATSTON Study
An observational study of Breast Cancer and Cardiovascular Diseases, run by UMC Utrecht at 3 sites in Netherlands.
Trial summary
The aim of the BRAGATSTON study is to provide a low cost tool for measuring CAC in breast cancer patients, thereby identifying patients at increased risk of CVD. Breast cancer patients and doctors can act upon this, by adapting the treatment and/or by adopting cardioprotective interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Cardiovascular Diseases
- How many people
- 16,000 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Jan 2017to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients treated with radiotherapy
Who may be able to join
- Breast cancer patients treated with radiotherapy in UMC Utrecht, Erasmus Medical Center or Radboudumc between 2004-16
- Planning CT scan available
- Age: ≥18 years
- Gender: both genders
Who cannot join
- Not applicable
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Radboudumc
Nijmegen
Erasmus Medical Center
Rotterdam
University Medical Center Utrecht
Utrecht
About this study
The aim of the BRAGATSTON study is to provide a low cost tool for measuring CAC in breast cancer patients, thereby identifying patients at increased risk of CVD. Breast cancer patients and doctors can act upon this, by adapting the treatment and/or by adopting cardioprotective interventions. Hereby, the burden of CVD in breast cancer survivors can be reduced and better overall survival rates can be achieved.
Read the detailed description
Cardiovascular disease (CVD) is the second most common cause of death in breast cancer patients. Certain adjuvant treatments (e.g. anthracyclines, radiotherapy) increase the risk of CVD, in particular in patients with pre-existing CVD risk factors. Early identification of these patients enables targeted cardioprotective interventions, and switching to less cardiotoxic treatments. The strongest independent CVD risk factor is the presence and amount of coronary artery calcium (CAC). In clinical practice, CAC is quantified on cardiac CTs. Breast cancer patients treated with radiotherapy routinely undergo planning CTs. These inferior quality CTs may give the opportunity to routinely assess CAC.
The BRAGATSTON study is a multicenter retrospective observational cohort study (UMC Utrecht, Erasmus Medical Center and Radboudumc). The project is divided into three work packages (WP), each WP with a unique aim:
WP 1: To develop/optimize and validate the UMC Utrecht developed automated software to determine the presence and the amount of CAC (CAC score) on radiotherapy planning CT scans of breast cancer patients.
WP 2a: To evaluate the association between CAC score measured automatically on planning CT scans and the risk of incident (non-)fatal cardiovascular events in breast cancer patients.
WP 2b: To evaluate if the association as defined by work package 2a is modified by type of adjuvant treatment.
WP 2c: To evaluate the association between other candidate imaging biomarkers (e.g. calcifications in other structures like the aorta or heart valves, the amount and distribution of body fat, bone characteristics) measured (automatically) on planning CT scans and the risk of incident (non-)fatal (cardiovascular) events in breast cancer patients.
WP 3: To assess the added value of CAC score measured automatically on planning CT scans over classic cardiovascular risk factors and over treatment characteristics to predict (non-)fatal cardiovascular events in breast cancer patients.
- Conditions
- Breast Cancer, Cardiovascular Diseases
- Keywords
- Breast cancer, Cardiovascular diseases, Coronary artery calcium, Prediction, Risk stratification, Deep learning technique, Software development, Computed tomography scan
- Medical subject headings
- Breast Neoplasms, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients treated with radiotherapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident (non-)fatal (cardiovascular) diseases
Measured: Up to 13 years of follow-up, in hazard ratios
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Jan 2017
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Retrospective
- Enrolment
- 16,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, Radboud University Medical Center
- Responsible party
- Principal investigator, Helena M Verkooijen, UMC Utrecht
- Investigators
- Helena M. Verkooijen, MD, PhD, Principal investigator, Imaging Division, University Medical Center Utrecht, UtrechtIvana Išgum, PhD, Principal investigator, Image Sciences Institute, University Medical Center Utrecht, UtrechtLuca Incrocci, MD, PhD, Principal investigator, Department of Radiation Oncology, Erasmus Medical Center, RotterdamHanneke Meijer, MD, PhD, Principal investigator, Department of Radiation Oncology, Radboudumc, Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206333
- Sponsor's protocol ID
- 16/721 (IRB UMC Utrecht)
- Status last verified
- Feb 2024
- First submitted
- 28 Jun 2017
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Gal R, van Velzen SGM, Hooning MJ, Emaus MJ, van der Leij F, Gregorowitsch ML, Blezer ELA, Gernaat SAM, Lessmann N, Sattler MGA, Leiner T, de Jong PA, Teske AJ, Verloop J, Penninkhof JJ, Vaartjes I, Meijer H, van Tol-Geerdink JJ, Pignol JP, van den Bongard DHJG, Isgum I, Verkooijen HM. Identification of Risk of Cardiovascular Disease by Automatic Quantification of Coronary Artery Calcifications on Radiotherapy Planning CT Scans in Patients With Breast Cancer. JAMA Oncol. 2021 Jul 1;7(7):1024-1032. doi: 10.1001/jamaoncol.2021.1144.
PubMed 33956083Emaus MJ, Isgum I, van Velzen SGM, van den Bongard HJGD, Gernaat SAM, Lessmann N, Sattler MGA, Teske AJ, Penninkhof J, Meijer H, Pignol JP, Verkooijen HM; Bragatston study group. Bragatston study protocol: a multicentre cohort study on automated quantification of cardiovascular calcifications on radiotherapy planning CT scans for cardiovascular risk prediction in patients with breast cancer. BMJ Open. 2019 Jul 27;9(7):e028752. doi: 10.1136/bmjopen-2018-028752.
PubMed 31352417
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Quantification of Coronary Artery Calcifications on Radiotherapy Planning CTs for Cardiovascular Risk Prediction in Breast Cancer Patients: the BRAGATSTON Study
- ClinicalTrials.gov ID
- NCT03206333
- Acronym / sponsor ID
- 16/721 (IRB UMC Utrecht)
- Conditions
- Breast Cancer, Cardiovascular Diseases
- Keywords
- Breast cancer, Cardiovascular diseases, Coronary artery calcium, Prediction, Risk stratification, Deep learning technique, Software development, Computed tomography scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,000 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, Radboud University Medical Center
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 2 Jul 2017 (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.
The aim of the BRAGATSTON study is to provide a low cost tool for measuring CAC in breast cancer patients, thereby identifying patients at increased risk of CVD. Breast cancer patients and doctors can act upon this, by adapting the treatment and/or by adopting cardioprotective interventions. Hereby, the burden of CVD in breast cancer survivors can be reduced and better overall survival rates can be achieved.
Detailed description
Cardiovascular disease (CVD) is the second most common cause of death in breast cancer patients. Certain adjuvant treatments (e.g. anthracyclines, radiotherapy) increase the risk of CVD, in particular in patients with pre-existing CVD risk factors. Early identification of these patients enables targeted cardioprotective interventions, and switching to less cardiotoxic treatments. The strongest independent CVD risk factor is the presence and amount of coronary artery calcium (CAC). In clinical practice, CAC is quantified on cardiac CTs. Breast cancer patients treated with radiotherapy routinely undergo planning CTs. These inferior quality CTs may give the opportunity to routinely assess CAC.
The BRAGATSTON study is a multicenter retrospective observational cohort study (UMC Utrecht, Erasmus Medical Center and Radboudumc). The project is divided into three work packages (WP), each WP with a unique aim:
WP 1: To develop/optimize and validate the UMC Utrecht developed automated software to determine the presence and the amount of CAC (CAC score) on radiotherapy planning CT scans of breast cancer patients.
WP 2a: To evaluate the association between CAC score measured automatically on planning CT scans and the risk of incident (non-)fatal cardiovascular events in breast cancer patients.
WP 2b: To evaluate if the association as defined by work package 2a is modified by type of adjuvant treatment.
WP 2c: To evaluate the association between other candidate imaging biomarkers (e.g. calcifications in other structures like the aorta or heart valves, the amount and distribution of body fat, bone characteristics) measured (automatically) on planning CT scans and the risk of incident (non-)fatal (cardiovascular) events in breast cancer patients.
WP 3: To assess the added value of CAC score measured automatically on planning CT scans over classic cardiovascular risk factors and over treatment characteristics to predict (non-)fatal cardiovascular events in breast cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients treated with radiotherapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients treated with radiotherapy
Key inclusion criteria (4 listed)
- Breast cancer patients treated with radiotherapy in UMC Utrecht, Erasmus Medical Center or Radboudumc between 2004-16
- Planning CT scan available
- Age: ≥18 years
- Gender: both genders
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incident (non-)fatal (cardiovascular) diseases
Time frame: Up to 13 years of follow-up, in hazard ratios
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Derived from this study: PubMed 33956083Gal R, van Velzen SGM, Hooning MJ, Emaus MJ, van der Leij F, Gregorowitsch ML, Blezer ELA, Gernaat SAM, Lessmann N, Sattler MGA, Leiner T, de Jong PA, Teske AJ, Verloop J, Penninkhof JJ, Vaartjes I, Meijer H, van Tol-Geerdink JJ, Pignol JP, van den Bongard DHJG, Isgum I, Verkooijen HM. Identification of Risk of Cardiovascular Disease by Automatic Quantification of Coronary Artery Calcifications on Radiotherapy Planning CT Scans in Patients With Breast Cancer. JAMA Oncol. 2021 Jul 1;7(7):1024-1032. doi: 10.1001/jamaoncol.2021.1144.
- Derived from this study: PubMed 31352417Emaus MJ, Isgum I, van Velzen SGM, van den Bongard HJGD, Gernaat SAM, Lessmann N, Sattler MGA, Teske AJ, Penninkhof J, Meijer H, Pignol JP, Verkooijen HM; Bragatston study group. Bragatston study protocol: a multicentre cohort study on automated quantification of cardiovascular calcifications on radiotherapy planning CT scans for cardiovascular risk prediction in patients with breast cancer. BMJ Open. 2019 Jul 27;9(7):e028752. doi: 10.1136/bmjopen-2018-028752.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Helena M. Verkooijen, MD, PhD principal investigator
Imaging Division, University Medical Center Utrecht, Utrecht
Ivana Išgum, PhD principal investigator
Image Sciences Institute, University Medical Center Utrecht, Utrecht
Luca Incrocci, MD, PhD principal investigator
Department of Radiation Oncology, Erasmus Medical Center, Rotterdam
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Cardiovascular Diseases, run by UMC Utrecht at 3 sites 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident (non-)fatal (cardiovascular) diseases (time frame: Up to 13 years of follow-up, in hazard ratios). 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 NCT03206333, which also lists 2 linked publications.
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 6 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.