STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy

NCT06337097 | Recruiting

• 2 other identifiers: 2023-1021NCI-2024-02687
• Study Type: interventional
• Target: 980
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Checkpoint Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Troponin Surveillance

EXPERIMENTAL

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

Diagnostic Test: Troponin surveillance

Standard of Care

EXPERIMENTAL

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

Other: Standard of care

Interventions

Troponin surveillance DIAGNOSTIC_TEST

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

Troponin Surveillance

Standard of care OTHER

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Nicolas Palaskas, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Palaskas, MD

CONTACT

(713) 606-3957; nlpalaskas@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: February 2, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)