Biomarkers to Predict Cancer Therapy-related Cardiotoxicity

NCT06353191 | Recruiting

• 4 other identifiers: 19-002566R01HL169268R56HL160643NCI-2024-00943
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

SUSPENDED

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Participants must consent to have their specimen retained for research use. Consent can be withdrawn at any time.

Study Officials

• Nadine Norton, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 8, 2024
• Study Start: May 3, 2019
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (4)