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Troponin Surveillance for Cancer immunotherapy

Phase 3
Recruiting
Led By Nicolas Palaskas, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights

Study Summary

This trial aims to see if checking the levels of a heart injury marker in cancer patients treated with immune checkpoint inhibitors can help reduce heart-related side effects.

Who is the study for?
This trial is for adults (18+) who are about to start cancer immunotherapy with immune checkpoint inhibitors and can consent to the study. It's not for those who are pregnant, breastfeeding, have a history of missing appointments, or any condition that might mess up the study results or increase their risk by participating.Check my eligibility
What is being tested?
The STRICT trial is testing whether monitoring troponin levels in the blood—a sign of heart injury—can reduce heart-related side effects in patients receiving standard cancer immunotherapy treatments.See study design
What are the potential side effects?
While specific side effects aren't listed here, immune checkpoint inhibitors can sometimes cause inflammation in organs including the heart (myocarditis), lung issues, liver problems, skin reactions, hormone gland changes and more.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and adverse events (AEs)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Troponin SurveillanceExperimental Treatment1 Intervention
Participants in Group 1, will have blood tests performed prior to each immune checkpoint inhibitor infusion for 12 weeks.
Group II: Standard of CareExperimental Treatment1 Intervention
Participants in Group 2, will have standard of care testing for any heart-related side effects of immune checkpoint inhibitors.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,788,594 Total Patients Enrolled
Nicolas Palaskas, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How large is the participant pool for this clinical investigation?

"Affirmative. The data sourced from clinicaltrials.gov confirms the active recruitment status of this study, which was first posted on February 2nd, 2024 and most recently updated on March 28th, 2024. Enrollment aims to reach a total of 880 participants at a single designated site."

Answered by AI

Is the current investigation open for participant enrollment?

"Indeed, information on clinicaltrials.gov highlights that this investigation is presently enrolling participants. Initially shared on February 2nd, 2024, and most recently revised on March 28th, 2024. The trial aims to recruit a total of 880 patients from one designated site."

Answered by AI

What risks are associated with Troponin Monitoring in individuals undergoing medical treatment?

"Scoring a 3 on the safety scale, Troponin Surveillance is deemed safe by our team at Power due to its Phase 3 trial status, which indicates both efficacy and robust safety data."

Answered by AI
~587 spots leftby Dec 2026