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Recruiting NCT06353191

Biomarkers to Predict Cancer Therapy-related Cardiotoxicity

— Observational Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Interventional Study.
Who it may be relevant to
Registry conditions: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Biomarkers to Predict Cancer Therapy-Related Cardiotoxicity

Overview

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.

OUTLINE: This is an observational study.

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

Interventions

  • Other Non-Interventional Study
    Non-interventional study

Primary outcome measures

  • Collection of biospecimens from patients who developed cardiac toxicity (CRCT) or who are at high risk for developing CRCT [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 4 centers
  • Mayo Clinic in Arizona — Scottsdale
  • Mayo Clinic in Florida — Jacksonville
  • Moffitt Cancer Center — Tampa
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06353191 · 19-002566 · R01HL169268 · R56HL160643 · NCI-2024-00943

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗