Atrial Fibrillation and Other Cardiac Arrhythmias and Diseases After Radiotherapy for Breast Cancer : Watch Your HeaRT

NCT06073509 | Unknown

• 1 other identifier: WATCH_2023
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Radiation Toxicity; Atrial Fibrillation; Cardiac Arrhythmia; Cardiac Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of AF

  AF previously diagnosed between RT and RT+5 years or silent AF incidentally diagnosed at 5-year post-RT screening

  5 years

Secondary Outcomes (2)

• Incidence of non AF cardiac arrhythmia

  5 years

• Incidence of other cardiac diseases

  5 years

Study Arms (1)

Breast cancer patients treated with RT 5 years ago

Retrospective and cross-sectional data collection based on a medical questionnaire and screening for atrial fibrillation and other cardiac arrhythmias and diseases.

Diagnostic Test: Screening for atrial fibrillation and other cardiac arrhythmias and diseases

Interventions

Screening for atrial fibrillation and other cardiac arrhythmias and diseases DIAGNOSTIC_TEST

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, ...)

Breast cancer patients treated with RT 5 years ago

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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,
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sophie JACOB: lead
• Clinique Pasteur Toulouse: collaborator
• Centre Francois Baclesse: collaborator
• Institut Curie: collaborator

Study Sites (1)

Clinique Pasteur

Toulouse, France

RECRUITING

Related Publications (1)

• Saint-Lary L, Pinel B, Panh L, Jimenez G, Geffrelot J, Kirova Y, Camilleri J, Broggio D, Bernier MO, Mandin C, Levy C, Boveda S, Thariat J, Jacob S. Screening and Risk Analysis of Atrial Fibrillation After Radiotherapy for Breast Cancer: Protocol for the Cross-Sectional Cohort Study "Watch Your Heart (WATCH)". JMIR Res Protoc. 2025 Jun 4;14:e67875. doi: 10.2196/67875.

  PMID: 40466092 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Radiation Injuries; Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases

Interventions

Mass Screening; Diagnosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Sophie Jacob, PhD

  Institut de Radioprotection et de Surete Nucleaire

  STUDY CHAIR

Central Study Contacts

Sophie Jacob, PhD

CONTACT

+33561145608; sophie.jacob@irsn.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Coordinator

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: October 25, 2023
• Primary Completion: October 20, 2025
• Study Completion: November 20, 2025
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

FR (1)