Biomarkers to Predict Cancer Therapy-related Cardiotoxicity

Biomarkers to Predict Cancer Therapy-Related Cardiotoxicity

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

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Non-Interventional Study

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Contact: Myrah Manuel; Phone Number: 480-574-3157; Email: Manuel.Myrah@mayo.edu
      • Principal Investigator: Lida A. Mina, MD
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Recruiting
      • Mayo Clinic in Florida
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Nadine Norton, Ph.D.
      • Contact: Pamela Williamson; Phone Number: 904-953-4694; Email: Williamson.Pamela@mayo.edu
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Suspended
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; Patients undergo blood sample collection and have their medical records reviewed on study.	Other: Non-Interventional Study; Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI); National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Nadine Norton, Ph.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Wounds and Injuries; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Neoplasms; Cardiotoxicity
• Other Study ID Numbers: 19-002566 (Other Identifier: Mayo Clinic in Florida); P30CA015083 (U.S. NIH Grant/Contract); NCI-2024-00943 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01HL169268 (U.S. NIH Grant/Contract); R56HL160643 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No