Cardiac Biomarkers in Patients Receiving Immune Checkpoint Inhibitors (PRIME-ICI)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSouth Tees Hospitals NHS Foundation Trust
About this trial
Immune checkpoint inhibitors (ICIs) are widely used cancer treatments. Blood tests such as cardiac troponin and N-terminal pro-B-type natriuretic peptide (NT-proBNP) can help clinicians investigate possible heart injury, but these markers may also be raised for other reasons such as infection, kidney dysfunction, arrhythmia, pulmonary embolism or fluid overload. PRIME-ICI is a prospective observational study of adults starting ICI therapy at The James Cook University Hospital. The study will mainly use leftover blood from routine clinical samples and routine electronic health-record data. Samples will be batch tested for NT-proBNP, high-sensitivity troponin I and T, and selected exploratory biomarkers. The study will determine how often cardiac biomarkers are elevated, describe the clinical circumstances in which elevations occur, and classify biomarker-positive episodes according to their most likely clinical phenotype. Participation does not alter cancer treatment, and research biomarker results are not used for real-time clinical decisions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Planned to start any immune checkpoint inhibitor-containing treatment (PD-1, PD-L1, CTLA-4 or combination therapy).
Enrolled at, or immediately prior to, ICI initiation, with residual blood available from routine clinical sampling where feasible.
Provision of informed consent.
Disqualifiers
Recent acute coronary syndrome within 1 month prior to enrolment.
Dialysis-dependent renal failure (patients with non-dialysis chronic kidney disease may be included and eGFR recorded).
Trial population
Adults with cancer treated at The James Cook University Hospital who are planned to start an immune checkpoint inhibitor-containing regimen and are enrolled at, or immediately prior to, ICI initiation. Patients already established on ICI therapy are not recruited.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 1 trial groupGroup A: Adults initiating immune checkpoint inhibitor therapy
Trial outcomes
Primary outcomes
1
Number of participants with cardiac biomarker elevation across evaluable biomarker episodes
Proportion of evaluable routine-treatment and acute admission/ED observation biomarker episodes in which NT-proBNP, hs-cTnI and/or hs-cTnT is above the applicable local laboratory upper limit of normal. Estimates will be reported with 95% confidence intervals.
Time frame
From baseline/ICI initiation through a minimum of 6 months follow-up2
Adjudicated clinical phenotype of biomarker-positive episodes
Distribution of biomarker-positive episodes across prespecified adjudicated phenotypes: ICI-associated myocarditis; heart failure/congestion; acute coronary syndrome/ischaemic myocardial injury; other cardiovascular illness; non-cardiovascular/systemic illness; and indeterminate/not assessable.
Time frame
From baseline/ICI initiation through a minimum of 6 months follow-upSecondary outcomes
1
Distribution of prespecified biomarker patterns
Number and proportion of biomarker-positive episodes classified as isolated NT-proBNP elevation, isolated troponin elevation, combined NT-proBNP/troponin elevation, or cardiac biomarker elevation accompanied by systemic/immune-toxicity biomarker abnormalities.
Time frame
From baseline/ICI initiation through a minimum of 6 months follow-up2
Classification against ICI-myocarditis diagnostic frameworks
Among biomarker-positive episodes with sufficient contemporaneous data, number/proportion meeting ESC/IC-OS criteria for ICI-associated myocarditis and description against locally implemented UKONS diagnostic/escalation thresholds. Episodes lacking sufficient data will be reported as not assessable.
Time frame
From baseline/ICI initiation through a minimum of 6 months follow-up3
Exploratory systemic biomarker abnormalities associated with cardiac biomarker elevation
Prevalence and magnitude of CK, ALT, AST and LDH abnormalities, together with available routine inflammatory, haematological and renal markers, in relation to cardiac biomarker elevation and adjudicated clinical phenotype.
Time frame
From baseline/ICI initiation through a minimum of 6 months follow-up4
Trajectory of cardiac biomarker abnormalities
Among episodes with biomarker elevation, subsequent available values will be used to describe whether levels normalise, improve, persist or worsen, and where possible the trajectory will be described in relation to clinical context, cardiovascular therapy, immunosuppression, ICI interruption and admission diagnosis.
Time frame
From baseline/ICI initiation through a minimum of 6 months follow-upSponsors and contacts
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Source ClinicalTrials.gov
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