Biomarkers to Predict Cancer Therapy-related Cardiotoxicity

August 14, 2026 updated by: Mayo Clinic

Biomarkers to Predict Cancer Therapy-Related Cardiotoxicity

This study evaluates why some cancer patients but not others experience changes in heart function following treatment with chemotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To collect biospecimens from 1) patients who developed chemotherapy related cardiac toxicity (CRCT) and 2) patients who are at a high risk for developing CRCT.

OUTLINE: This is an observational study.

Patients undergo blood sample collection and have their medical records reviewed on study. Patients may also optionally undergo ECG on study.

Study Type

Observational

Enrollment (Estimated)

693

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Principal Investigator:
          • Aixa Soyano, MD
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Suspended
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who were treated for any malignancy with any type of chemotherapy including oral, parenteral therapy and immunotherapy

Description

Inclusion Criteria:

  • 18 years of age or older
  • Treated for any malignancy with any type of chemotherapy including oral, parenteral therapy and immunotherapy

  • One of the following:

    • Diagnosed with cardiotoxicity defined as; cardiomyopathy, symptomatic heart failure, asymptomatic reduced systolic function, acute coronary syndrome, myocardial infarction, critical limb ischemia, cardiac arrhythmias or myocarditis possibly related to prior cancer treatment
    • Completed chemotherapy with no cardiotoxicity at least two years post treatment
    • Patients with cancer who will be initiating systemic therapy with potentially cardiotoxic medications. This will include chemotherapy, immunotherapy, targeted therapy that have been associated with cardiac toxicity
  • An understanding of the protocol and its requirements, risks, and discomforts
  • The ability and willingness to sign an informed consent

Exclusion Criteria:

- Inability on the part of the patient to understand the informed consent or be compliant with the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Patients undergo blood sample collection and have their medical records reviewed on study. Patients may also optionally undergo ECG on study.
Other: Non-Interventional Study
Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection of biospecimens from patients who developed cardiac toxicity (CRCT) or who are at high risk for developing CRCT
Time Frame: Baseline
Assessed by the number of participants who participate and consent to have their specimen (blood draw) retained for future research.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Nadine Norton, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2019

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 14, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-002566 (Mayo Clinic Institutional Review Board)
  • NCI-2024-00943 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R01HL169268 (U.S. NIH Grant/Contract)
  • R56HL160643 (U.S. NIH Grant/Contract)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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