Monitoring heart injury in cancer patients receiving immune checkpoint therapy
STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy
This study tests if checking blood levels of a heart injury marker can help cancer patients on immune checkpoint therapy avoid heart problems and improve their treatment experience.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 980 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06337097 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if tracking blood levels of troponin, a marker for heart injury, can help reduce heart-related side effects in cancer patients undergoing treatment with immune checkpoint inhibitors. It focuses on various cardiovascular events, including myocarditis and heart failure, and assesses the time to diagnosis and hospitalization duration for these events. The study will also evaluate the impact of troponin monitoring on cancer progression and the need for additional cardiac testing.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are planning to receive immune checkpoint inhibitors as part of their cancer treatment.
Not a fit: Patients who have had a major adverse cardiovascular event within 30 days prior to enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved cardiovascular safety and outcomes for cancer patients receiving immune checkpoint therapy.
How similar studies have performed: While monitoring cardiac biomarkers in cancer patients is a growing area of interest, this specific approach to troponin surveillance during immune checkpoint therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Nicolas Palaskas, MD — M.D. Anderson Cancer Center
- Study coordinator: Nicolas Palaskas, MD
- Email: nlpalaskas@mdanderson.org
- Phone: (713) 606-3957
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.