Heart blood tests in people with cancer starting immune checkpoint inhibitors

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with cancer who are about to start immune checkpoint inhibitor treatment at The James Cook University Hospital. It studies heart blood tests using leftover routine blood samples.

Age

18 years or older

Sex

All sexes

Disease stage

Cancer treated with an immune checkpoint inhibitor (PD-1, PD-L1, CTLA-4 or combination therapy).

Earlier treatment

People must be planned to start an immune checkpoint inhibitor treatment. They join at the start of this treatment or just before it.

Main reasons for not taking part

• A recent heart attack or similar sudden heart problem (acute coronary syndrome) within 1 month before joining
• Kidney failure that needs dialysis (people with kidney disease not on dialysis can join)

The registry criteria, word for word

What the trial wants to find out

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.

The group in the trial

• Adults initiating immune checkpoint inhibitor therapy

  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.