Not yet recruitingOBSERVATIONAL

Cardiac Biomarkers in Patients Receiving Immune Checkpoint Inhibitors (PRIME-ICI)

This study, called PRIME-ICI, is for people in the UK who are starting a modern cancer treatment called immune checkpoint inhibitors (ICIs). These powerful treatments help your body fight cancer, but they can sometimes affect the heart. We are looking at blood tests, like troponin and NT-proBNP, which can show if there might be a problem with the heart. However, these blood markers can also go up for other reasons, like an infection or kidney issues. The study aims to understand how often these markers are raised in people having ICI treatment, and to figure out the real reason behind any increases. This will help doctors better understand what’s happening with their patients and decide on the best care. Taking part won't change your cancer treatment.

At a glance

Status

Not yet recruiting

Sponsor

South Tees Hospitals NHS Foundation Trust

Enrolment target

300

Start

12 Oct 2026

Estimated completion

31 Mar 2028

Cardiotoxicity Cardiac Biomarkers Cancer

What is this study about?

Many people with cancer are now treated with special medicines called immune checkpoint inhibitors, or ICIs. These medicines help your own immune system find and fight cancer cells. They are very effective, but like all strong medicines, they can sometimes have side effects. One area doctors are keen to understand better is how these treatments might affect the heart.

Your body produces natural substances called 'biomarkers' that can be measured in your blood. When your heart is under stress or slightly damaged, some of these markers, like troponin and NT-proBNP, can go up. This study, called PRIME-ICI, wants to learn more about these heart markers in people starting ICI cancer treatment. We know that these markers can also increase for other reasons, like having an infection, kidney problems, or even being very dehydrated.

By carefully looking at the results of these blood tests alongside other health information, the study aims to understand exactly when these heart markers rise during ICI treatment. It will help us figure out if a rise in these markers is truly due to the heart, or if it's because of another common problem. This information will be really valuable for doctors to interpret blood test results more accurately, and to make better decisions about how to care for patients receiving these important cancer drugs.

Key takeaways

This study helps understand heart markers in people having cancer treatment.
It aims to tell if a raised heart marker is due to the heart or another problem.
You must be starting a specific type of cancer treatment called ICIs.
Participation mainly uses leftover blood from your routine tests.
Your cancer treatment will not be affected by joining this study.
The information gained could improve care for future cancer patients.

Who may be eligible?

You might be able to join this study if you are an adult, aged 18 or older.

Crucially, you must be about to start a new course of cancer treatment that includes immune checkpoint inhibitor (ICI) medicines. These medicines might have names like PD-1, PD-L1, or CTLA-4 inhibitors, or be a combination of them. The study aims to look at your blood from before you start this treatment, and then while you're having it.

However, you won't be able to join if you've had a recent heart attack (in the last month) or if you need regular kidney dialysis.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you about to start a new cancer treatment that includes immune checkpoint inhibitor (ICI) medicines?
Have you *not* had a heart attack in the last month?
Do you *not* need regular kidney dialysis?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your cancer treatment won't change at all – you’ll still receive the same care your doctors planned. The study mainly uses small amounts of blood that are left over from routine blood tests you'd be having anyway for your cancer care. This means you generally won't need to have extra needles or blood taken just for the study.

Occasionally, if there isn't enough leftover blood from your first visit, you might be asked if a small extra blood sample can be taken at the same time as your first treatment. The study team will also look at your routine health records, such as test results and doctor's notes, for at least 6 months after you start treatment. There are no extra hospital visits or special appointments involved. Your participation lasts for as long as the study team continues to review your routine records, which will be at least 6 months.

Potential risks and benefits

Taking part in this study means you are contributing to important research that will help doctors understand more about how cancer treatments affect the heart. This understanding could lead to better care for future patients. There are very few direct risks to you, as the study mostly uses blood samples you're already giving for your routine care and reviews existing health records. If an extra blood sample is needed, the risk is similar to any routine blood test, such as a small bruise. There are no direct benefits to your own health from taking part, as the study results won't change your immediate care. Remember, you can always change your mind and withdraw from the study at any time, without it affecting your cancer treatment or care in any way.

Locations (1)

Academic Cardiovascular Unit, James Cook University Hospital
Verified postcode
Middlesbrough, United Kingdom

Common questions

What are immune checkpoint inhibitors (ICIs)?

ICIs are a type of cancer medicine that helps your body's own defence system (immune system) recognise and fight cancer cells more effectively.

What are 'cardiac biomarkers'?

These are natural substances measured in your blood that can show if your heart is under stress or has been slightly damaged.

Will taking part in this study change my cancer treatment?

No, your cancer treatment will not change at all. You will receive the same care as planned by your doctors.

Do I need extra blood tests for this study?

Mostly, no. The study uses leftover blood from your routine tests. Only rarely, if there isn't enough leftover blood, might a small extra sample be taken with your first treatment.

Why is this study important?

It helps doctors understand when heart markers go up during cancer treatment, making it easier to tell if it's a heart issue or something else, leading to better care for patients.

How to find out more

Saif Memon, MBBS

saif.memon@nhs.net +44 (0)1642 850 850 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.