STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy

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

• Status: Recruiting
• Conditions: Immune Checkpoint Therapy
• Intervention / Treatment: Diagnostic test: Troponin surveillance; Other: Standard of care

Detailed Description

Primary Objectives:

• Myocarditis CTCAE version 5.0 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): 980
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas Palaskas, MD; Phone Number: (713) 606-3957; Email: nlpalaskas@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Principal Investigator: Nicolas Palaskas, MD
      • Contact: Nicolas Palaskas, MD; Phone Number: 713-606-3957; Email: nlpalaskas@mdanderson.org

Participation Criteria

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:

• Troponin T not available at screening or prior to randomization
• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and adverse events (AEs)	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

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

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

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): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• 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