Cancer Survivor Cardiomyopathy Detection (CASCADE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Cancer
• Intervention / Treatment: Diagnostic test: NT-pro-BNP; Diagnostic test: Electrocardiogram; Diagnostic test: Echocardiogram

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 Type: Observational
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

200 cancer survivors who are 1 year out from anthracycline-based therapy.

Description

Inclusion Criteria:

• ≥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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1 year follow-up; patients who were treated in the year before and are now returning for their 1-year follow-up.	Diagnostic test: NT-pro-BNP; Blood draw; Other Names: Blood Biomarker; Diagnostic test: Electrocardiogram; electrodes are placed on certain spots and a reading obtained to measure the voltage of the heart; Diagnostic test: Echocardiogram; medical imaging of the heart
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.	Diagnostic test: NT-pro-BNP; Blood draw; Other Names: Blood Biomarker; Diagnostic test: Electrocardiogram; electrodes are placed on certain spots and a reading obtained to measure the voltage of the heart; Diagnostic test: Echocardiogram; medical imaging of the heart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	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%	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%	1 year post anthracycline therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Florida Heart Research Institute
• Investigators: Principal Investigator: Joerg Herrmann, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 20, 2026

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Neoplasms; Cardiovascular Diseases; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Electrodiagnosis; Cardiac Imaging Techniques; Ultrasonography; Electrocardiography; Echocardiography
• Other Study ID Numbers: CASCADE; 21-006790 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2022-05920 (Registry Identifier: CTRP (Clinical Trials Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No