Identifying heart risks in cancer patients after chemotherapy
Biomarkers to Predict Cancer Therapy-Related Cardiotoxicity
This study is trying to find out why some cancer patients have heart problems after chemotherapy while others don't, by looking at their blood samples and medical records.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 4 sites (Scottsdale, Arizona and 3 other locations) |
| Trial ID | NCT06353191 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand why some cancer patients experience heart function changes after chemotherapy while others do not. It involves collecting blood samples and reviewing medical records from patients who have developed chemotherapy-related cardiac toxicity and those at high risk for it. The study focuses on patients treated for various malignancies with different chemotherapy regimens, including immunotherapy and targeted therapies. By analyzing biospecimens, researchers hope to identify biomarkers that predict cardiac toxicity in these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have received chemotherapy for any malignancy and either experienced cardiac toxicity or are at high risk for it.
Not a fit: Patients who are unable to understand the informed consent process will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prediction and management of heart-related side effects in cancer patients undergoing chemotherapy.
How similar studies have performed: Other studies have explored similar approaches to understanding chemotherapy-related cardiac toxicity, indicating a growing interest in this area of research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Scottsdale, Arizona and 3 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Suspended)
Study contacts
- Principal investigator: Nadine Norton, PhD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.