Cardiovascular DiseasesCASCADENCT05201014
Cancer Survivor Cardiomyopathy Detection
An observational study of Cardiovascular Diseases and Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to improve the cardiovascular care of adult cancer survivors. The goal is to obtain the data necessary to plan and develop a nation-wide network of a screening program that can help provide cost-effective and long-term monitoring. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiovascular Diseases, Cancer
- What is being tested?
- NT-pro-BNP, Electrocardiogram and Echocardiogram
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2022to 9 Feb 2026
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200 cancer survivors who are 1 year out from anthracycline-based therapy.
Who may be able to join
- ≥18 years of age prior to enrollment and anthracycline start date
- Diagnosis of breast cancer, lymphoma, or sarcoma with either planned or at 1 year after completion of anthracycline therapy, including patients from 6-12 months and greater than 1 year post-anthracycline exposure.
- Patients with a history of persistent atrial fibrillation (afib) that are not in afib remission. Include if the most recent ECG does not show afib. Atrial flutter treated the same
Who cannot join
- LVEF <50% or prior confirmed history of cardiomyopathy, heart failure, left bundle branch block, or paced rhythm
- Patients with a history of persistent atrial fibrillation (afib) that are not in afib remission. Include if the most recent ECG does not show afib. Atrial flutter treated the same.
- Individuals with pacemakers, defibrillators, or other implanted electronic devices
- Inability/unwillingness of individual to give written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: CAncer Survivor CArdiomyopathy DEtection Pilot Study
The purpose of this study is to improve the cardiovascular care of adult cancer survivors. The goal is to obtain the data necessary to plan and develop a nation-wide network of a screening program that can help provide cost-effective and long-term monitoring.
Read the detailed description
The primary objective of this study is to define the diagnostic performance and optimal cutoffs of AI-ECG and NT-pro-BNP for the detection of left ventricular dysfunction [LVD, defined as a left ventricular ejection fraction (LVEF) <50%] in cancer patients at 1 year after completion of anthracycline-based chemotherapy.
- Conditions
- Cardiovascular Diseases, Cancer
- Being tested
- NT-pro-BNP, Electrocardiogram, Echocardiogram
- Medical subject headings
- Cardiovascular Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-pro-BNPDiagnostic test
Also called Blood Biomarker
Blood draw
ElectrocardiogramDiagnostic test
electrodes are placed on certain spots and a reading obtained to measure the voltage of the heart
EchocardiogramDiagnostic test
medical imaging of the heart
| Study group | Role | What they receive |
|---|---|---|
| 1 year follow-up | patients who were treated in the year before and are now returning for their 1-year follow-up. Receives: Diagnostic Test: NT-pro-BNP; Diagnostic Test: Electrocardiogram; Diagnostic Test: Echocardiogram | |
| Prior to anthracycline-based therapy | patients presenting before the start of anthracycline-based therapy, then to be followed thereafter for 1 year and thereby contributing to the pool of patients with 1-year post-anthracycline assessment. Receives: Diagnostic Test: NT-pro-BNP; Diagnostic Test: Electrocardiogram; Diagnostic Test: Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of AI-ECG for left ventricular ejection fraction (LVEF) < 50%
Determination of the sensitivity, specificity, positive and negative prediction value as well as area under the curve for receiver operating characteristics for the 12-lead AI ECG algorithm for an LVEF <50%
Measured: 1 year post anthracycline therapy
Diagnostic performance of NT-pro-BNP for left ventricular ejection fraction (LVEF) < 50%
Determination of the sensitivity, specificity, positive and negative prediction value as well as area under the curve for receiver operating characteristics for NT-pro-BNP >125 for an LVEF <50%
Measured: 1 year post anthracycline therapy
Diagnostic performance of AI-ECG and NT-pro-BNP for left ventricular ejection fraction (LVEF) < 50%
Determination of the sensitivity, specificity, positive and negative prediction value as well as area under the curve for receiver operating characteristics for the 12-lead AI ECG algorithm and NT-pro-BNP >125 combined for an LVEF <50%
Measured: 1 year post anthracycline therapy
Secondary outcomes (5)
Absolute change in LVEF from baseline to 1 year from anthracycline-based therapy
Calculation of the the change in LVEF from baseline to 1 year from anthracycline-based therapy
Measured: 1 year
Absolute change in AI-ECG probability for LVEF <50% from baseline to 1 year from anthracycline-based therapy
Calculation of the change in AI-ECG probability of LVEF <50% from baseline to 1 year from anthracycline-based therapy
Measured: 1 year
Correlation of change in LVEF and AI-ECG probability of LVEF <50% from baseline to 1 year from anthracycline-based therapy
Calculation of the correlation coefficient of change in LVEF and AI-ECG probability of LVEF <50% from baseline to 1 year from anthracycline-based therapy
Measured: 1 year
Absolute change in NT-pro-BNP from baseline to 1 year from anthracycline-based therapy
Calculation of the change NT-pro-BNP from baseline to 1 year from anthracycline-based therapy
Measured: 1 year
Correlation of change in LVEF and NT-pro-BNP from baseline to 1 year from anthracycline-based therapy
Calculation of the correlation coefficient of change in LVEF and NT-pro-BNP from baseline to 1 year from anthracycline-based therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start3 Mar 2022
- Primary completion9 Feb 2026
- Study completion9 Feb 2026
Why it stopped: diminished funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Heart Research Institute
- Responsible party
- Principal investigator, Joerg Herrmann, MD, Mayo Clinic
- Investigators
- Joerg Herrmann, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201014
- Sponsor's protocol ID
- CASCADE
- Other IDs
- NCI-2022-05920, 21-006790
- Acronym
- CASCADE
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2021
- Last updated
- 10 Aug 2026
- 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAncer Survivor CArdiomyopathy DEtection Pilot Study
- ClinicalTrials.gov ID
- NCT05201014
- Acronym / sponsor ID
- CASCADE / CASCADE
- Conditions
- Cardiovascular Diseases, Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: diminished funding
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Florida Heart Research Institute
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 21 Jan 2022 (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 improve the cardiovascular care of adult cancer survivors. The goal is to obtain the data necessary to plan and develop a nation-wide network of a screening program that can help provide cost-effective and long-term monitoring.
Detailed description
The primary objective of this study is to define the diagnostic performance and optimal cutoffs of AI-ECG and NT-pro-BNP for the detection of left ventricular dysfunction [LVD, defined as a left ventricular ejection fraction (LVEF) <50%] in cancer patients at 1 year after completion of anthracycline-based chemotherapy.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 year follow-up | – | Diagnostic Test: NT-pro-BNP, Diagnostic Test: Electrocardiogram, Diagnostic Test: Echocardiogrampatients who were treated in the year before and are now returning for their 1-year follow-up. |
| Prior to anthracycline-based therapy | – | Diagnostic Test: NT-pro-BNP, Diagnostic Test: Electrocardiogram, Diagnostic Test: Echocardiogrampatients presenting before the start of anthracycline-based therapy, then to be followed thereafter for 1 year and thereby contributing to the pool of patients with 1-year post-anthracycline assessment. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 cancer survivors who are 1 year out from anthracycline-based therapy.
Key inclusion criteria (3 listed)
- ≥18 years of age prior to enrollment and anthracycline start date
- Diagnosis of breast cancer, lymphoma, or sarcoma with either planned or at 1 year after completion of anthracycline therapy, including patients from 6-12 months and greater than 1 year post-anthracycline exposure.
- Patients with a history of persistent atrial fibrillation (afib) that are not in afib remission. Include if the most recent ECG does not show afib. Atrial flutter treated the same
Key exclusion criteria (4 listed)
- LVEF <50% or prior confirmed history of cardiomyopathy, heart failure, left bundle branch block, or paced rhythm
- Patients with a history of persistent atrial fibrillation (afib) that are not in afib remission. Include if the most recent ECG does not show afib. Atrial flutter treated the same.
- Individuals with pacemakers, defibrillators, or other implanted electronic devices
- Inability/unwillingness of individual to give written informed consent
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 |
|---|---|---|
| NT-pro-BNPAlso: Blood BiomarkerBlood draw | Diagnostic test | 1 year follow-up, Prior to anthracycline-based therapy |
| Electrocardiogramelectrodes are placed on certain spots and a reading obtained to measure the voltage of the heart | Diagnostic test | 1 year follow-up, Prior to anthracycline-based therapy |
| Echocardiogrammedical imaging of the heart | Diagnostic test | 1 year follow-up, Prior to anthracycline-based therapy |
Primary outcome
Diagnostic performance of AI-ECG for left ventricular ejection fraction (LVEF) < 50%
Time frame: 1 year post anthracycline therapy
Determination of the sensitivity, specificity, positive and negative prediction value as well as area under the curve for receiver operating characteristics for the 12-lead AI ECG algorithm for an LVEF <50%
Diagnostic performance of NT-pro-BNP for left ventricular ejection fraction (LVEF) < 50%
Time frame: 1 year post anthracycline therapy
Determination of the sensitivity, specificity, positive and negative prediction value as well as area under the curve for receiver operating characteristics for NT-pro-BNP >125 for an LVEF <50%
Diagnostic performance of AI-ECG and NT-pro-BNP for left ventricular ejection fraction (LVEF) < 50%
Time frame: 1 year post anthracycline therapy
Determination of the sensitivity, specificity, positive and negative prediction value as well as area under the curve for receiver operating characteristics for the 12-lead AI ECG algorithm and NT-pro-BNP >125 combined for an LVEF <50%
5 secondary outcomes
Absolute change in LVEF from baseline to 1 year from anthracycline-based therapy
Time frame: 1 year
Absolute change in AI-ECG probability for LVEF <50% from baseline to 1 year from anthracycline-based therapy
Time frame: 1 year
Correlation of change in LVEF and AI-ECG probability of LVEF <50% from baseline to 1 year from anthracycline-based therapy
Time frame: 1 year
Absolute change in NT-pro-BNP from baseline to 1 year from anthracycline-based therapy
Time frame: 1 year
Correlation of change in LVEF and NT-pro-BNP from baseline to 1 year from anthracycline-based therapy
Time frame: 1 year
Results and safety
The study was stopped early (reason given: diminished funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
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?
An observational study of Cardiovascular Diseases and Cancer, 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 10 Aug 2026. 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?
The study was stopped early (reason given: diminished funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of AI-ECG for left ventricular ejection fraction (LVEF) < 50% (time frame: 1 year post anthracycline therapy). 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 10 Aug 2026.