An observational study in Cardiotoxicity, Cardiac Biomarkers and Cancer, sponsored by South Tees Hospitals NHS Foundation Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by South Tees Hospitals NHS Foundation Trust · Observational
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.
PRIME-ICI is a single-centre prospective observational cohort study enrolling adults at, or immediately prior to, the start of an immune checkpoint inhibitor-containing treatment regimen. Patients already established on ICI therapy are not recruited, in order to reduce survivorship and selection bias. Participants are followed through review of the electronic patient record for a minimum of 6 months.
The study primarily uses residual blood remaining after routine clinical testing. Residual samples obtained before ICI initiation, at available routine ICI/SACT treatment visits, and during acute hospital admissions or emergency-department observation episodes are identified where feasible and stored for later batch analysis. If no suitable residual baseline sample remains, one additional small baseline research blood sample may be taken at the first ICI treatment visit in accordance with the approved consent process.
The primary cardiac biomarkers are NT-proBNP, high-sensitivity cardiac troponin T (hs-cTnT), and high-sensitivity cardiac troponin I (hs-cTnI). Exploratory biomarkers include creatine kinase, alanine aminotransferase, aspartate aminotransferase and lactate dehydrogenase where sufficient sample is available and testing is analytically feasible. Contemporaneous routine clinical laboratory and clinical data are also collected where available.
Biomarker-positive episodes are described according to prespecified biomarker patterns and undergo structured clinical review using available routine clinical data. Adjudicated phenotypes include ICI-associated myocarditis, heart failure/congestion, acute coronary syndrome or ischaemic myocardial injury, other cardiovascular illness, non-cardiovascular/systemic illness, and indeterminate/not assessable. Where sufficient information is available, episodes are evaluated against ESC/IC-OS criteria for ICI-associated myocarditis and locally implemented UKONS thresholds. The study is designed to characterise background biomarker elevation and its clinical context; it is not powered to determine myocarditis incidence or diagnostic sensitivity/specificity.
264 studies on the registry are indexed under Cardiotoxicity; 72 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 125 observational studies indexed under Cardiotoxicity.
Browse Cardiotoxicity studies →South Tees Hospitals NHS Foundation Trust is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Adults aged 18 years or older enrolled at, or immediately prior to, initiation of any ICI-containing treatment regimen at The James Cook University Hospital. Participants receive cancer treatment according to routine clinical care; the study does not assign treatment.
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-up
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-up
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-up
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-up
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-up
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-up
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — No external individual participant-level dataset is currently planned for public sharing; aggregate results will be disseminated.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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South Tees Hospitals NHS Foundation Trust