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Trial Title:
Atrial Fibrillation and Other Cardiac Arrhythmias and Diseases After Radiotherapy for Breast Cancer : Watch Your HeaRT
NCT ID:
NCT06073509
Condition:
Breast Cancer
Radiation Toxicity
Atrial Fibrillation
Cardiac Arrhythmia
Cardiac Disease
Conditions: Official terms:
Breast Neoplasms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Screening for atrial fibrillation and other cardiac arrhythmias and diseases
Description:
In addition to retrospective data collection based on a medical questionnaire, a 5-year
post-RT cardiovascular screening will include:
- connected smartwatches for atrial fibrillation screening
- complete ECG for other cardiac arrhythmias
- echocardiography for other cardiac diseases (including cardiac dysfunction,
cardiomyopathy, valvulopathy, ...)
Arm group label:
Breast cancer patients treated with RT 5 years ago
Summary:
The goal of this interventional study is to evaluate the risk of atrial fibrillation (AF)
and other cardiac arrhythmias and diseases in breast cancer patients treated with
radiation therapy (RT).
In addition to regular follow-up of patients by the radiation oncologist for 5 years,
cardiovascular screening at the end of follow-up, combining the use of a connected watch
and a cardiological check-up, could make it possible to identify precisely the types and
frequencies of these sometimes asymptomatic, and probably underestimated, cardiac
diseases.
The main questions it aims to answer are:
- To assess the incidence of AF and other cardiac arrhythmias and diseases occurring
within 5 years after RT
- To evaluate absorbed doses in the heart and cardiac substructures (chambers,
conduction nodes, coronaries, pulmonary veins) based on auto-segmentation models
developped with deep learning algorithms
- To investigate whether the risk of AF and other cardiac arrhythmias and diseases is
associated with cardiac irradiation characterized by these absorbed doses
(dose-response relationship)
Participants will be included between 2023 and 2025, 5 years after their RT:
- Retrospective data collection will be based on a medical questionnaire designed to
identify cardiac pathologies present prior to RT and those having occured in the
past, between RT and 5 years post-RT.
- Cross-sectional data collection will be based on screening for cardiac pathologies
using a connected watch worn for 1 month (silent AF screening) and a cardiology
consultation (including ECG and echocardiography) to identify cardiac pathologies at
5 years post-RT possibly not identified in the retrospective data collection.
Criteria for eligibility:
Study pop:
Patients treated with RT for breast cancer 5 years ago who come at radiotherapy service
Clinique Pasteur for their last visit as part of the regular follow-up of patients by the
radiation oncologist for 5 years.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Women treated surgically for primary cancer of the left or right breast and for whom
adjuvant treatment is RT with irradiation of the breast or chest wall and possibly
irradiation of lymph node chains,
- Adjuvant radiotherapy performed at Clinique Pasteur between 2018 and 2020,
- 5-year post-RT follow-up radiation oncologist consultation performed at Clinique
Pasteur
- Age ≥ 65 years at the time of the 5-year post-RT follow-up consultation
- Own a smartphone and able to understand and use digital tools alone and/or with the
help of a caregiver ;
- Patient having consented to connected follow-up,
- Be affiliated to a social security scheme or equivalent
- Be willing to participate in the study and have signed the consent form
Exclusion Criteria:
- History of cancer before breast cancer RT
- Recurrence of breast cancer or other cancer treated after breast cancer RT
- History of atrial fibrillation prior to breast cancer RT
Gender:
Female
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinique Pasteur
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Gaëlle Jimenez, MD
Investigator:
Last name:
Serge Boveda, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Baptiste Pinel, MD
Email:
Sub-Investigator
Investigator:
Last name:
Loic Panh, MD
Email:
Sub-Investigator
Start date:
October 25, 2023
Completion date:
November 20, 2025
Lead sponsor:
Agency:
Sophie JACOB
Agency class:
Other
Collaborator:
Agency:
Clinique Pasteur Toulouse
Agency class:
Other
Collaborator:
Agency:
Centre Francois Baclesse
Agency class:
Other
Collaborator:
Agency:
Institut Curie
Agency class:
Other
Source:
Institut de Radioprotection et de Surete Nucleaire
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06073509
