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Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer

NCT03297346 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2023-11-07

No results posted yet for this study

Summary

Breast cancer (BC) radiotherapy leads to coincidental radiation of the heart, resulting in increased risk of a variety of heart diseases. Identifying BC patients with the highest risk of radiation-induced cardiac complications is crucial for developing strategies for primary and secondary prevention. Little has been done on the relationship between dose distribution to different anatomical cardiac structures during radiotherapy and early cardiovascular changes that may lead to cardiac complications.

In the framework of the European project MEDIRAD, the EARLY-HEART multicenter prospective cohort was launched in August 2017, involving 5 investigating centers from France, Netherlands, Germany, Spain and Portugal. With 250 BC patients prospectively followed for 2 years, the main objective is to identify and validate the most important cardiac imaging (echocardiography, computed tomography coronary angiography, cardiac magnetic resonance imaging) and circulating biomarkers of radiation-induced cardiovascular changes arising in the first 2 years after BC radiotherapy.

Conditions

  • Breast Cancer Female

Interventions

OTHER

Cardiac imaging and circulating biomarkers

Automated 2D-speckle-tracking echocardiography (ECHO-ST); Computed tomography coronary angiography (CT); Cardiac magnetic resonance imaging (MRI); Blood samples for circulating biomarkers measurements (BLOOD)

Sponsors & Collaborators

  • Academisch Ziekenhuis Groningen

    collaborator OTHER

  • Technical University of Munich

    collaborator OTHER

  • Institut Català d'Oncologia

    collaborator OTHER

  • Hospital de Santa Maria, Portugal

    collaborator OTHER

  • University of Paris 5 - Rene Descartes

    collaborator OTHER

  • Institut de Radioprotection et de Surete Nucleaire

    lead OTHER_GOV

Principal Investigators

  • Sophie Jacob, PhD · Institut de Radioprotection et de Sûreté Nucléaire

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2020-10-01
Completion
2021-05-31

Countries

  • France
  • Germany
  • Netherlands
  • Portugal
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03297346 on ClinicalTrials.gov