Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events (MEDIRAD-BRACE)

February 26, 2024 updated by: University Medical Center Groningen

Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events (MEDIRAD-BRACE): A Retrospective Cohort Study

MEDIRAD-BRACE aims to determine the relationship between 3D dose distributions in cardiac structures and the risk of acute coronary events (ACE) and other cardiac complications in breast cancer (BC) patients to develop and externally validate multivariable Normal Tissue Complication Probability (NTCP) models to assess the risk of ACE in individual patients based on cardiac dose metrics in the first 10 years after BC radiotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700RB
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult, female patients with stage I-III breast cancer, treated with primary surgery, either by mastectomy of breast conserving surgery, and postoperative RT in the period 2005-2013, and who were aged 40-75 years at the time of RT

Description

Inclusion Criteria:

  • Female breast cancer patients;
  • Treated with primary surgery for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS);
  • Age between 40-75 years at time of start RT;
  • WHO performance status 0-1;
  • Planned for RT alone to the breast, the chest wall and/or the lymph node areas;
  • Start of RT is between 01-01-2015 and 31-12-2013;
  • Available planning CT scan and dose distribution;
  • Adjuvant systemic treatment, including hormonal therapy or chemotherapy is allowed;
  • Medical history of coronary artery disease and/or myocardial infarction is not an exclusion criterion;
  • Written informed consent.

Exclusion Criteria:

  • Male breast cancer patients;
  • Women with metastatic breast cancer (M1 disease);
  • Any prior malignancy other than non-melanoma skin cancer;
  • Previous thoracic or mediastinal radiation;
  • Women treated with neoadjuvant chemotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with an Acute Coronary Event after completion of RT treatment
Time Frame: First 10 years after RT treatment
First 10 years after RT treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with other cardiac complications after completion of RT treatment
Time Frame: First 10 years after RT treatment
First 10 years after RT treatment
Number of patients with radiotherapy-induced late non-cardiac toxicity (e.g. secondary tumors)
Time Frame: First 10 years after RT treatment
First 10 years after RT treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

Technical University of Munich
The Netherlands Cancer Institute
Institut de Radioprotection et de Surete Nucleaire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

July 6, 2017

First Submitted That Met QC Criteria

July 6, 2017

First Posted (Actual)

July 7, 2017

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT2017-08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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