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NCT06353191 Clinical Trial

Biomarkers to Predict Cancer Therapy-related Cardiotoxicity

Malignant Solid Neoplasm Clinical Trial

Official title:
Biomarkers to Predict Cancer Therapy-Related Cardiotoxicity

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06353191
Other study ID # 19-002566
Secondary ID NCI-2024-0094319
Status Recruiting
Phase
First received
Last updated
Start date May 3, 2019
Est. completion date June 1, 2026

Study information
Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date June 1, 2026
Est. primary completion date June 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations
Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida
United States Mayo Clinic in Rochester Rochester Minnesota
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (3)
Lead Sponsor Collaborator
Mayo Clinic National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

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