Breast CancerWATCHNCT06073509
Atrial Fibrillation and Other Cardiac Arrhythmias and Diseases After Radiotherapy for Breast Cancer : Watch Your HeaRT
An observational study of Breast Cancer and Radiation Toxicity, run by Sophie JACOB at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Cancer, Radiation Toxicity, Atrial Fibrillation
- What is being tested?
- Screening for atrial fibrillation and other cardiac arrhythmias and diseases
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2023to 20 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Clinique Pasteur
Toulouse
Gaëlle Jimenez, MD
Serge Boveda, MD, PhD
About this study
Official title: Watch Your HeaRT Study - Screening and Risk Analysis of Atrial Fibrillation and Other Cardiac Arrhythmias and Diseases After Radiotherapy for Breast Cancer
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.
Read more
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
- Being tested
- Screening for atrial fibrillation and other cardiac arrhythmias and diseases
- Medical subject headings
- Breast Neoplasms, Radiation Injuries, Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for atrial fibrillation and other cardiac arrhythmias and diseasesDiagnostic 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, ...)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Screening for atrial fibrillation and other cardiac arrhythmias and diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AF
AF previously diagnosed between RT and RT+5 years or silent AF incidentally diagnosed at 5-year post-RT screening
Measured: 5 years
Secondary outcomes (2)
Incidence of non AF cardiac arrhythmia
non AF arrhythmia previously diagnosed between RT and RT+5 years and/or incidentally diagnosed at 5-year post-RT screening
Measured: 5 years
Incidence of other cardiac diseases
other cardiac diseases previously diagnosed between RT and RT+5 years and/or incidentally diagnosed at 5-year post-RT
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start25 Oct 2023
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sophie JACOB
- Sponsor type
- Other government
- Collaborators
- Clinique Pasteur Toulouse, Centre Francois Baclesse, Institut Curie
- Responsible party
- Sponsor-investigator, Sophie JACOB, French Nuclear Safety and Radiation Protection Authority (ASNR)
- Investigators
- Sophie Jacob, PhD, Study chair, French Nuclear Safety and Radiation Protection Authority (ASNR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073509
- Sponsor's protocol ID
- WATCH_2023
- Acronym
- WATCH
- Status last verified
- Nov 2023
- First submitted
- 4 Oct 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40466092
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Watch Your HeaRT Study - Screening and Risk Analysis of Atrial Fibrillation and Other Cardiac Arrhythmias and Diseases After Radiotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT06073509
- Acronym / sponsor ID
- WATCH / WATCH_2023
- Conditions
- Breast Cancer, Radiation Toxicity, Atrial Fibrillation, Cardiac Arrhythmia, Cardiac Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sophie JACOBOther government
- Collaborators
- Clinique Pasteur Toulouse, Centre Francois Baclesse, Institut Curie
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients treated with RT 5 years ago | – | Diagnostic Test: Screening for atrial fibrillation and other cardiac arrhythmias and diseasesRetrospective and cross-sectional data collection based on a medical questionnaire and screening for atrial fibrillation and other cardiac arrhythmias and diseases. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (8 listed)
- 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 ;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening for atrial fibrillation and other cardiac arrhythmias and diseasesIn 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, ...) | Diagnostic test | Breast cancer patients treated with RT 5 years ago |
Primary outcome
Incidence of AF
Time frame: 5 years
AF previously diagnosed between RT and RT+5 years or silent AF incidentally diagnosed at 5-year post-RT screening
2 secondary outcomes
Incidence of non AF cardiac arrhythmia
Time frame: 5 years
Incidence of other cardiac diseases
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Derived from this study: PubMed 40466092Saint-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Jacob, PhD study chair
French Nuclear Safety and Radiation Protection Authority (ASNR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Radiation Toxicity, run by Sophie JACOB at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie Jacob, PhD (+33561145608, sophie.jacob@irsn.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AF (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06073509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.