Immune Checkpoint TherapyNCT06337097
STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy
A study testing Troponin surveillance in people with Immune Checkpoint Therapy, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Checkpoint Therapy
- What is being tested?
- Troponin surveillance
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 980 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Nicolas Palaskas, MD, 713-606-3957, nlpalaskas@mdanderson.org
Nicolas Palaskas, MD
About this study
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.
Read the 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
- Being tested
- Troponin surveillance, Standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Troponin surveillanceDiagnostic test
Troponin will be monitored prior to each immune checkpoint inhibitor infusion for the first 12 weeks of therapy.
Standard of careOther
Standard of care if symptoms arise then evaluation with cardiac biomarkers and/or further cardiac testing.
| Study group | Role | What they receive |
|---|---|---|
| Troponin Surveillance | Experimental | Participants in Group 1, will have blood tests performed prior to each immune checkpoint inhibitor infusion for 12 weeks. Receives: 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. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start2 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Checkpoint TherapyStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 980 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Palaskas, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337097
- Sponsor's protocol ID
- 2023-1021
- Other IDs
- NCI-2024-02687
- Status last verified
- Aug 2026
- First submitted
- 22 Mar 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy
- ClinicalTrials.gov ID
- NCT06337097
- Acronym / sponsor ID
- 2023-1021
- Conditions
- Immune Checkpoint Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 980 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Troponin Surveillance | Experimental | Diagnostic Test: Troponin surveillanceParticipants in Group 1, will have blood tests performed prior to each immune checkpoint inhibitor infusion for 12 weeks. |
| Standard of Care | Experimental | Other: Standard of careParticipants in Group 2, will have standard of care testing for any heart-related side effects of immune checkpoint inhibitors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Troponin surveillanceTroponin will be monitored prior to each immune checkpoint inhibitor infusion for the first 12 weeks of therapy. | Diagnostic test | Troponin Surveillance |
| Standard of careStandard of care if symptoms arise then evaluation with cardiac biomarkers and/or further cardiac testing. | Other | Standard of Care |
Primary outcome
Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas Palaskas, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Troponin surveillance in people with Immune Checkpoint Therapy, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Palaskas, MD ((713) 606-3957, nlpalaskas@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.