LymphomaNCT07058064
WATCH (Wearable Artificial inTelligence for Cardiac Function and Health Monitoring)
A study testing Electrocardiogram, Echocardiogram and LVEF echocardiogram in people with Lymphoma and Sarcoma, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to find a cost effective cardiovascular (CV) surveillance of cancer survivors over long periods of time to prevent the risk of progression of heart failure (HF) and related morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Electrocardiogram, Echocardiogram and LVEF echocardiogram
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2025to 29 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ability to understand study procedures and being willing to comply with them for the entire study length
- diagnosis of lymphoma or sarcoma with new start or 1 year after completion of anthracycline therapy
Who cannot join
- LVEF <50% at baseline, or prior confirmed history of heart failure, persistent atrial fibrillation, left bundle branch block, or paced rhythm
- Unwilling or unable to give written informed consent
- Participants who have opted out of the Minnesota Research Authorization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Tera Peck, 507-538-7425, Peck.Tera@mayo.edu
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
About this study
The purpose of this study is to find a cost effective cardiovascular (CV) surveillance of cancer survivors over long periods of time to prevent the risk of progression of heart failure (HF) and related morbidity and mortality. Mobile device-based artificial intelligence (AI)-electrocardiogram (ECG) can reliably detect cardiac dysfunction in lymphoma and sarcoma survivors and smart watch based surveillance for cardiotoxicity is feasible and reliable.
- Being tested
- Electrocardiogram, Echocardiogram, LVEF echocardiogram, Apple Watch, Biospecimen collection
- Medical subject headings
- Lymphoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocardiogramProcedure or surgery
Also called ECG, EKG
All participants receive a standard 12-lead ECG when they present for follow-up 1 year after completion of anthracycline-based therapy. All participants will also record a 6-lead Kardia (AliveCor, Mountain View, CA, USA) and 1-lead Apple Watch (Apple, Cupertino, CA, USA) ECG with Mayo-owned or participant-owned devices.
Longitudinal participants will receive an Apple Watch to use during this study if they do not have their own (and agree to download the app) and will be able to transmit ECGs anytime anywhere from their Apple Watch from before the initiation, all through the treatment, up to 1-year after anthracycline-based therapy. For validation, these participants will transmit ECGs from their smart watch at the time of routine follow-up visits (at 3-, 6- \& 9-months post therapy visits) along with 6-lead Kardia ECGs, and 12-lead standard ECGs.
EchocardiogramProcedure or surgery
Also called echo, cardiac ultrasound, heart ultrasound
All participants will have an echocardiogram as part of standard of care when they present for their follow-up 1 year after completion of anthracycline-based therapy.
LVEF echocardiogramProcedure or surgery
Also called Left ventricular ejection fraction (LVEF) echocardiogram, LVEF echo
Participants will undergo a limited LVEF echocardiogram at the 6-month post therapy visit.
Apple WatchOther
Longitudinal participants will receive an Apple Watch to use during this study if they do not have their own (and agree to download the app) and will be able to transmit ECGs anytime anywhere from their Apple Watch from before the initiation, all through the treatment, up to 1-year after anthracycline-based therapy. For validation, these participants will transmit ECGs from their smart watch at the time of routine follow-up visits (at 3-, 6- \& 9-months post therapy visits) along with 6-lead Kardia ECGs, and 12-lead standard ECGs.
Longitudinal participants will be asked to transmit weekly cardio fitness (estimates of peak VO2) from baseline to 1-year post therapy.
Biospecimen collectionProcedure or surgery
Also called Blood draw
Undergo blood draw
QuestionnairesOther
Participants fill out 2 questionnaires: 1) the Kansas City Cardiomyopathy-12 (KCCQ-12) Questionnaire, and 2) the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) ore 30 (EORTC QLQ-C30) to evaluate health related quality of life and heart failure symptoms.
Cardio-pulmonary exercise testOther
Also called CPET
Undergo CPET to assess the response of heart and lungs to exercise.
6 minute walk testOther
Also called 6MWT
Complete a 6MWT, to see how far participants can walk on a hard, flat surface for 6 minutes
Grip strength testOther
A hand-held device called a dynamometer will be used to measure the muscle strength in hand/forearm
| Study group | Role | What they receive |
|---|---|---|
| Cross-sectional Arm | Active comparator | Lymphoma and sarcoma cancer survivors will be seen at one time point, 1 year after completion of anthracycline-based therapy. Receives: Procedure: Electrocardiogram; Procedure: Echocardiogram; Procedure: LVEF echocardiogram; Procedure: Biospecimen collection; Other: Questionnaires |
| Longitudinal Arm | Experimental | Lymphoma and sarcoma cancer survivors will be seen before the start of anthracycline-based therapy and followed every three months up to 1 year after completion of therapy. Longitudinal participants will have the option of recording ECG and cardio fitness data through an Apple Watch from before up to 1 year post anthracycline treatment. Receives: Procedure: Electrocardiogram; Procedure: Echocardiogram; Procedure: LVEF echocardiogram; Other: Apple Watch; Procedure: Biospecimen collection; Other: Questionnaires; Other: Cardio-pulmonary exercise test; Other: 6 minute walk test; Other: Grip strength test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of left left ventricular ejection fraction (LVEF) <50% by AI-ECG
Mobile device ECGs will be compared to standard 12-lead clinic ECGs for the AI algorithm to predict a reduced EF (EF <50%).
Measured: Baseline to 1 year follow-up
Change in AI-ECG based probability of an LVEF <50% using mobile device ECGs
The change in probability of abnormal LVEF by AI-ECG using mobile device ECG will be compared between patients who do develop a reduction in LVEF over time versus those who do not.
Measured: Baseline to 1 year follow-up
Change in peak VO2
Volume of Oxygen (VO2) will be estimated by the Apple Watch algorithm (developed by Apple Inc.) and reviewed for change from baseline to 1 year.
Measured: Baseline to 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start18 Jul 2025
- Primary completion29 Jun 2029 (estimated)
- Study completion29 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joerg Herrmann, MD, Mayo Clinic
- Investigators
- Joerg Herrmann, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058064
- Sponsor's protocol ID
- 25-002911
- Other IDs
- NCI-2025-04631, 25-002911, HT94252510309
- Status last verified
- Oct 2025
- First submitted
- 1 Jul 2025
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WATCH (Wearable Artificial inTelligence for Cardiac Function and Health Monitoring)
- ClinicalTrials.gov ID
- NCT07058064
- Acronym / sponsor ID
- 25-002911
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 29 Jun 2029 (estimated)
- Study completion
- 29 Jun 2029 (estimated)
- First posted
- 10 Jul 2025 (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 purpose of this study is to find a cost effective cardiovascular (CV) surveillance of cancer survivors over long periods of time to prevent the risk of progression of heart failure (HF) and related morbidity and mortality. Mobile device-based artificial intelligence (AI)-electrocardiogram (ECG) can reliably detect cardiac dysfunction in lymphoma and sarcoma survivors and smart watch based surveillance for cardiotoxicity is feasible and reliable.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-sectional Arm | Active comparator | Procedure: Electrocardiogram, Procedure: Echocardiogram, Procedure: LVEF echocardiogram, Procedure: Biospecimen collection, Other: QuestionnairesLymphoma and sarcoma cancer survivors will be seen at one time point, 1 year after completion of anthracycline-based therapy. |
| Longitudinal Arm | Experimental | Procedure: Electrocardiogram, Procedure: Echocardiogram, Procedure: LVEF echocardiogram, Other: Apple Watch, Procedure: Biospecimen collection, Other: Questionnaires, Other: Cardio-pulmonary exercise test, Other: 6 minute walk test, Other: Grip strength testLymphoma and sarcoma cancer survivors will be seen before the start of anthracycline-based therapy and followed every three months up to 1 year after completion of therapy. Longitudinal participants will have the option of recording ECG and cardio fitness data through an Apple Watch from before up to 1 year post anthracycline treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ability to understand study procedures and being willing to comply with them for the entire study length
- diagnosis of lymphoma or sarcoma with new start or 1 year after completion of anthracycline therapy
Key exclusion criteria (3 listed)
- LVEF <50% at baseline, or prior confirmed history of heart failure, persistent atrial fibrillation, left bundle branch block, or paced rhythm
- Unwilling or unable to give written informed consent
- Participants who have opted out of the Minnesota Research Authorization
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 |
|---|---|---|
| ElectrocardiogramAlso: ECG, EKGAll participants receive a standard 12-lead ECG when they present for follow-up 1 year after completion of anthracycline-based therapy. All participants will also record a 6-lead Kardia (AliveCor, Mountain View, CA, USA) and 1-lead Apple Watch (Apple, Cupertino, CA, USA) ECG with Mayo-owned or participant-owned devices. Longitudinal participants will receive an Apple Watch to use during this study if they do not have their own (and agree to download the app) and will be able to transmit ECGs anytime anywhere from their Apple Watch from before the initiation, all through the treatment, up to 1-year after anthracycline-based therapy. For validation, these participants will transmit ECGs from their smart watch at the time of routine follow-up visits (at 3-, 6- \& 9-months post therapy visits) along with 6-lead Kardia ECGs, and 12-lead standard ECGs. | Procedure or surgery | Cross-sectional Arm, Longitudinal Arm |
| EchocardiogramAlso: echo, cardiac ultrasound, heart ultrasoundAll participants will have an echocardiogram as part of standard of care when they present for their follow-up 1 year after completion of anthracycline-based therapy. | Procedure or surgery | Cross-sectional Arm, Longitudinal Arm |
| LVEF echocardiogramAlso: Left ventricular ejection fraction (LVEF) echocardiogram, LVEF echoParticipants will undergo a limited LVEF echocardiogram at the 6-month post therapy visit. | Procedure or surgery | Cross-sectional Arm, Longitudinal Arm |
| Apple WatchLongitudinal participants will receive an Apple Watch to use during this study if they do not have their own (and agree to download the app) and will be able to transmit ECGs anytime anywhere from their Apple Watch from before the initiation, all through the treatment, up to 1-year after anthracycline-based therapy. For validation, these participants will transmit ECGs from their smart watch at the time of routine follow-up visits (at 3-, 6- \& 9-months post therapy visits) along with 6-lead Kardia ECGs, and 12-lead standard ECGs. Longitudinal participants will be asked to transmit weekly cardio fitness (estimates of peak VO2) from baseline to 1-year post therapy. | Other | Longitudinal Arm |
| Biospecimen collectionAlso: Blood drawUndergo blood draw | Procedure or surgery | Cross-sectional Arm, Longitudinal Arm |
| QuestionnairesParticipants fill out 2 questionnaires: 1) the Kansas City Cardiomyopathy-12 (KCCQ-12) Questionnaire, and 2) the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) ore 30 (EORTC QLQ-C30) to evaluate health related quality of life and heart failure symptoms. | Other | Cross-sectional Arm, Longitudinal Arm |
| Cardio-pulmonary exercise testAlso: CPETUndergo CPET to assess the response of heart and lungs to exercise. | Other | Longitudinal Arm |
| 6 minute walk testAlso: 6MWTComplete a 6MWT, to see how far participants can walk on a hard, flat surface for 6 minutes | Other | Longitudinal Arm |
| Grip strength testA hand-held device called a dynamometer will be used to measure the muscle strength in hand/forearm | Other | Longitudinal Arm |
Primary outcome
Detection of left left ventricular ejection fraction (LVEF) <50% by AI-ECG
Time frame: Baseline to 1 year follow-up
Mobile device ECGs will be compared to standard 12-lead clinic ECGs for the AI algorithm to predict a reduced EF (EF <50%).
Change in AI-ECG based probability of an LVEF <50% using mobile device ECGs
Time frame: Baseline to 1 year follow-up
The change in probability of abnormal LVEF by AI-ECG using mobile device ECG will be compared between patients who do develop a reduction in LVEF over time versus those who do not.
Change in peak VO2
Time frame: Baseline to 1 year follow-up
Volume of Oxygen (VO2) will be estimated by the Apple Watch algorithm (developed by Apple Inc.) and reviewed for change from baseline to 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
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.
Joerg Herrmann, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocardiogram, Echocardiogram and LVEF echocardiogram in people with Lymphoma and Sarcoma, run by Mayo Clinic at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 15 Oct 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tera Peck (507-266-2123, Peck.Tera@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of left left ventricular ejection fraction (LVEF) <50% by AI-ECG (time frame: Baseline to 1 year follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2025.