STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy

March 28, 2024 updated by: M.D. Anderson Cancer Center
To learn if monitoring blood levels of heart injury (troponin levels) in cancer participants treated with immune checkpoint inhibitors will lead to decreased heart-related side effects.

Study Overview

Detailed Description

Primary Objectives:

To compare the incidence of major adverse cardiovascular events between the 2 study arms. Major adverse cardiovascular events will be defined as the first of any of the following cardiac conditions to occur; Myocarditis CTCAE grade >=3, Ventricular tachycardia (>=30 seconds), Advanced atrioventricular block, Incident heart failure event, Cardiovascular mortality, Non-fatal sudden cardiac arrest, Acute coronary syndrome, Pericarditis, Pericardial tamponade.

Secondary Objectives:

  • Time from symptom onset to diagnosis of major adverse cardiovascular events
  • Time from symptom onset to diagnosis of myocarditis
  • Initial hospitalization duration for the adverse cardiovascular event from primary endpoint
  • Peak biomarker levels including troponin T, troponin I, creatine kinase, and creatine kinase myocardial band
  • Percentage of patients with negative workup for myocarditis
  • Percentage of patients requiring major cardiac testing including echocardiograms, cardiac magnetic resonance imaging, and/or invasive heart catheterization
  • Duration of interruption and/or discontinuation of immune checkpoint inhibitor therapy
  • Cancer progression free survival
  • Time to next cancer therapy

Study Type

Interventional

Enrollment (Estimated)

880

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Principal Investigator:
          • Nicolas Palaskas, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female patient ≥18 years old
  • Plan for treatment with an immune checkpoint inhibitor as standard of care even if patient is also on an additional investigational cancer therapeutic
  • Willingness to provide informed consent

Exclusion Criteria:

  • Pregnant or breast-feeding
  • Inability to comply with planned study procedures
  • Major adverse cardiovascular event included in the primary outcome within the 30 days prior to enrollment
  • Any medical condition that could interfere with, or for which the treatment might interfere with the conduct of the study or interpretation of the study results, or that would, in the opinion of the investigator, increase the risk of the participant by participating in the study
  • Any factors that, in the Investigator's opinion, are likely to interfere with study procedures, such as history of noncompliance with scheduled appointments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Troponin Surveillance
Participants in Group 1, will have blood tests performed every 2 weeks for 12 weeks.
Troponin will be monitored prior to each immune checkpoint inhibitor infusion for the first 12 weeks of therapy.
Experimental: Standard of Care
Participants in Group 2, will have standard of care testing for any heart-related side effects of immune checkpoint inhibitors.
Standard of care if symptoms arise then evaluation with cardiac biomarkers and/or further cardiac testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and adverse events (AEs)
Time Frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Through study completion; an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nicolas Palaskas, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2023-1021
  • NCI-2024-02687 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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