CARDiac Toxicity Following ImmunOtherapy Treatment for Melanoma
This study, called CARD-IO, aims to understand the longer-term effects of immunotherapy treatments for melanoma on the heart. Immunotherapy is very effective for melanoma, but it can sometimes cause side effects, including rare but serious heart problems. While doctors check for these problems during treatment, there isn't much information about what happens to the heart many years later. This research will investigate if it's practical to carry out heart tests on people who had immunotherapy for melanoma 2 to 10 years ago. The goal is to gather information that could help improve guidelines and ongoing care for these patients, ensuring their heart health is looked after for many years to come.
At a glance
What is this study about?
When people have a type of skin cancer called melanoma, they are often treated with special medicines known as immunotherapy. These medicines, called Immune Checkpoint Inhibitors (ICI), are very good at fighting cancer. However, like many powerful treatments, they can sometimes cause side effects, which doctors call 'immune-related adverse events' (irAEs). These side effects can happen anywhere in the body and can be mild or, in rare cases, very serious.
While we know a lot about the short-term side effects of immunotherapy, we don't know as much about how these treatments might affect someone's health, particularly their heart, many years down the line. Although heart-related side effects during immunotherapy are uncommon, they can be serious when they do occur. There's a suggestion that immunotherapy might, over time, contribute to issues like the build-up of fatty materials in arteries, which could increase the risk of heart problems like heart attacks.
Currently, there are no specific guidelines for regularly checking the hearts of people who have successfully finished immunotherapy for melanoma and are now healthy survivors. This CARD-IO study wants to find out if it's possible and practical to do these types of checks. The information gathered from this small study will help design a bigger study in the future. Ultimately, this research could lead to new guidelines, ensuring that people who have had immunotherapy for melanoma receive the best long-term care for their heart health.
Key takeaways
- Immunotherapy for melanoma can have long-term side effects, potentially affecting the heart.
- This study aims to find out if it's possible to check for these long-term heart effects in melanoma survivors.
- The research could lead to better long-term heart monitoring for patients who received immunotherapy.
- Participation involves heart scans (ECG, echocardiogram, MRI) and blood tests.
- The study focuses on adults who finished immunotherapy 2-10+ years ago.
- Your routine medical care will not be affected if you choose not to participate.
Who may be eligible?
This study is looking for adults aged 18 or older who have been diagnosed with melanoma that was either Stage IIB, IIC, III, or IV. You must have received immunotherapy treatment for your melanoma in the past, specifically immune-checkpoint inhibitors (like anti PD-(L)1 or anti CTLA-4, or both).
An important part of joining is that you should currently be receiving your regular follow-up care for melanoma and it should be between 2 and 10 or more years since you finished your immunotherapy treatment.
Unfortunately, you wouldn't be able to join if you have any medical or psychological condition that would prevent you from understanding and giving your written consent. Also, if you have any reasons why you couldn't have an MRI scan (like severe claustrophobia, being pregnant, or having certain metal implants in your body), or if you are currently having active treatment for any cancer (including a new cancer that started after your melanoma immunotherapy), this study wouldn't be right for you. People who are planning to join another drug trial or who can't keep up with the study appointments would also not be able to take part.
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?
- Have you been diagnosed with Stage IIB, IIC, III, or IV melanoma?
- Have you previously received immunotherapy (like anti PD-(L)1 or anti CTLA-4) for your melanoma?
- Is it 2 to 10 or more years since you finished your immunotherapy treatment?
- Are you currently receiving your regular follow-up care for melanoma?
- Are you able to have an MRI scan (e.g., no severe claustrophobia, no unsafe metal implants)?
What does participation involve?
If you join this study, you will have several tests to check your heart health. These will include blood tests to look at certain heart markers and fats, a standard heart tracing called a 12-lead ECG, and an ultrasound scan of your heart known as a transthoracic echocardiogram. You will also have a type of scan called a cardiac MRI, which gives a detailed picture of your heart.
These assessments will take place at a single hospital visit, around 2 to 10 years after you completed your immunotherapy. The study will look at patient groups at different time points after their treatment. The aim is to see how easy it is for people to join the study and complete all these tests.
Potential risks and benefits
Locations (1)
- The Royal Marsden NHS Foundation TrustVerified postcodeLondon, United Kingdom
Common questions
What is immunotherapy for melanoma?
It's a powerful medicine (like Immune Checkpoint Inhibitors) that helps your body's own immune system fight melanoma cancer cells.
What are 'irAEs'?
These are side effects caused by immunotherapy when your immune system becomes overactive and attacks healthy parts of your body. They can affect various organs.
Why is the study focusing on the heart?
While heart-related side effects from immunotherapy are rare, they can be serious. This study wants to understand if there are long-term heart effects years after treatment, as not much is known about this.
Will I receive new treatment in this study?
No, this is an 'observational' study. You will not receive any new medicines. It involves tests to check your heart health, not treatment.
How long has to have passed since my immunotherapy?
You need to be 2 to 10 or more years past completing your immunotherapy treatment for melanoma to be considered for this study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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