NCT03206333

Brief 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. Hereby, the burden of CVD in breast cancer survivors can be reduced and better overall survival rates can be achieved.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

3.2 years

First QC Date

June 28, 2017

Last Update Submit

February 5, 2024

Conditions

Breast CancerCardiovascular Diseases

Keywords

Breast cancerCardiovascular diseasesCoronary artery calciumPredictionRisk stratificationDeep learning techniqueSoftware developmentComputed tomography scan

Outcome Measures

Primary Outcomes (1)

  • Incident (non-)fatal (cardiovascular) diseases

    Up to 13 years of follow-up, in hazard ratios

Study Arms (1)

Breast cancer patients treated with radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Breast cancer patients treated with radiotherapy

You may qualify if:

  • 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

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Radboudumc

Nijmegen, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 33956083DERIVED

  • Emaus 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.

    PMID: 31352417DERIVED

MeSH Terms

Conditions

Breast NeoplasmsCardiovascular Diseases

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Helena M. Verkooijen, MD, PhD

    Imaging Division, University Medical Center Utrecht, Utrecht

    PRINCIPAL INVESTIGATOR

  • Ivana Išgum, PhD

    Image Sciences Institute, University Medical Center Utrecht, Utrecht

    PRINCIPAL INVESTIGATOR

  • Luca Incrocci, MD, PhD

    Department of Radiation Oncology, Erasmus Medical Center, Rotterdam

    PRINCIPAL INVESTIGATOR

  • Hanneke Meijer, MD, PhD

    Department of Radiation Oncology, Radboudumc, Nijmegen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 28, 2017

First Posted

July 2, 2017

Study Start

January 1, 2017

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

Locations

NL(3)