Biomarkers to Predict Cancer Therapy-related Cardiotoxicity

Recruiting

• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06353191
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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 identified prior to the onset of therapy.

OUTLINE: This is an observational study.

Patients undergo blood sample collection and have their medical records reviewed on study.

Study Timeline

• Study Start: 2019-05-03
• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-03
• Study First Posted: 2024-04-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• * 18 years of age or older

  • Treated for any malignancy with any type of chemotherapy including oral, parenteral therapy and immunotherapy
  • 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 OR completed chemotherapy with no cardiotoxicity at least two years post treatment OR 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients undergo blood sample collection and have their medical records reviewed on study.

Primary Outcome Measures

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

Trial Locations

Locations (4)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States