STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy

NCT ID: NCT06337097

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 980 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-02
• Study Completion Date: 2028-12-31

Brief Summary

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.

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

Conditions

Immune Checkpoint Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Troponin Surveillance

Participants in Group 1, will have blood tests performed prior to each immune checkpoint inhibitor infusion for 12 weeks.

Group Type: EXPERIMENTAL

Troponin surveillance

Intervention Type: DIAGNOSTIC_TEST

Troponin will be monitored prior to each immune checkpoint inhibitor infusion for the first 12 weeks of therapy.

Standard of Care

Participants in Group 2, will have standard of care testing for any heart-related side effects of immune checkpoint inhibitors.

Group Type: EXPERIMENTAL

Standard of care

Intervention Type: OTHER

Standard of care if symptoms arise then evaluation with cardiac biomarkers and/or further cardiac testing.

Interventions

Troponin surveillance

Troponin will be monitored prior to each immune checkpoint inhibitor infusion for the first 12 weeks of therapy.

Intervention Type: DIAGNOSTIC_TEST

Standard of care

Standard of care if symptoms arise then evaluation with cardiac biomarkers and/or further cardiac testing.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Palaskas, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

MD Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nicolas Palaskas, MD

Role: CONTACT

nlpalaskas@mdanderson.org

(713) 606-3957

Facility Contacts

Nicolas Palaskas, MD

Role: primary

nlpalaskas@mdanderson.org

713-606-3957

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

NCI-2024-02687

Identifier Type: OTHER

Identifier Source: secondary_id

2023-1021

Identifier Type: -

Identifier Source: org_study_id