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CASCADE: Cancer Survivor Cardiomyopathy Detection

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05201014
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: NT-pro-BNP
  • Diagnostic Test: Electrocardiogram
  • Diagnostic Test: Echocardiogram
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two subsets of patients will be enrolled in parallel with the launch of this study. Subset one will be patients who were treated in the year before and are now returning for their 1-year follow-up. Subset two will be 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. With 100 patients in each subset this will allow a) to recruit 200 patients with 1-year post anthracycline therapy follow-up over a two- year period and b) to serially follow, before and after, half of the patients.Two subsets of patients will be enrolled in parallel with the launch of this study. Subset one will be patients who were treated in the year before and are now returning for their 1-year follow-up. Subset two will be 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. With 100 patients in each subset this will allow a) to recruit 200 patients with 1-year post anthracycline therapy follow-up over a two- year period and b) to serially follow, before and after, half of the patients.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Cancer Survivor Cardiomyopathy Detection
Actual Study Start Date :
Mar 3, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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
    Active Comparator: 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

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic performance of AI-ECG for left ventricular ejection fraction (LVEF) < 50% [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%

    2. Diagnostic performance of NT-pro-BNP for left ventricular ejection fraction (LVEF) < 50% [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%

    3. Diagnostic performance of AI-ECG and NT-pro-BNP for left ventricular ejection fraction (LVEF) < 50% [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%

    Secondary Outcome Measures

    1. Absolute change in LVEF from baseline to 1 year from anthracycline-based therapy [1 year]

      Calculation of the the change in LVEF from baseline to 1 year from anthracycline-based therapy

    2. Absolute change in AI-ECG probability for LVEF <50% from baseline to 1 year from anthracycline-based therapy [1 year]

      Calculation of the change in AI-ECG probability of LVEF <50% from baseline to 1 year from anthracycline-based therapy

    3. Correlation of change in LVEF and AI-ECG probability of LVEF <50% from baseline to 1 year from anthracycline-based therapy [1 year]

      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

    4. Absolute change in NT-pro-BNP from baseline to 1 year from anthracycline-based therapy [1 year]

      Calculation of the change NT-pro-BNP from baseline to 1 year from anthracycline-based therapy

    5. Correlation of change in LVEF and NT-pro-BNP from baseline to 1 year from anthracycline-based therapy [1 year]

      Calculation of the correlation coefficient of change in LVEF and NT-pro-BNP from baseline to 1 year from anthracycline-based therapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ≥18 years of age at the time of enrollment

    • diagnosis of breast cancer, lymphoma, or sarcoma with either planned or at 1 year after completion of anthracycline therapy.

    Exclusion Criteria:

    • LVEF <50% or prior confirmed history of cardiomyopathy, heart failure, persistent atrial fibrillation, left bundle branch block, or paced rhythm

    • Individuals with pacemakers, defibrillators or other implanted electronic devices

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Joerg Herrmann, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Joerg Herrmann, MD, Professor of Medicine, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05201014
    Other Study ID Numbers:
    • 21-006790
    First Posted:
    Jan 21, 2022
    Last Update Posted:
    Apr 8, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Cardiomyopathies

    Study Results

    No Results Posted as of Apr 8, 2022