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Biomarkers to Predict Cancer Therapy-related Cardiotoxicity

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Mayo Clinic

Status

Enrolling

Conditions

Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm

Treatments

Other: Non-Interventional Study

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT06353191
19-002566 (Other Identifier)
NCI-2024-00943 (Registry Identifier)
R01HL169268 (U.S. NIH Grant/Contract)
R56HL160643 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

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

Trial contacts and locations

4

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Central trial contact

Clinical Trials Referral Office

Data sourced from clinicaltrials.gov

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