Biomarkers to Predict Cancer Therapy-related Cardiotoxicity | NCT06353191

Studies
Biomarkers to Predict Cancer Therapy-related Cardiotoxicity

NCT06353191

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Feb 27, 2026Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm

Interventions

Non-Interventional Study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01HL169268	U.S. NIH Grant/Contract		View source
R56HL160643	U.S. NIH Grant/Contract		View source
NCI-2024-00943	Registry Identifier	CTRP (Clinical Trial Reporting Program)
19-002566	Other Identifier	Mayo Clinic Institutional Review Board

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 3, 2019Actual

Primary Completion Date

Dec 31, 2031Estimated

Completion Date

Dec 31, 2031Estimated

First Submitted Date

Apr 3, 2024

First Submission Date that Met QC Criteria

Apr 3, 2024

First Posted Date

Apr 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2026

Last Update Posted Date

Feb 27, 2026Actual

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

OUTLINE: This is an observational study.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional Study	Other	Non-interventional study	Observational

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who were treated for any malignancy with any type of chemotherapy including oral, parenteral therapy and immunotherapy

Sampling Method

Non-Probability Sample