RecruitingOBSERVATIONAL

Understanding immunE-related toXicities by multifACeT Profiling

This study, called EXACT, is looking to understand more about side effects that can occur with a type of cancer treatment called immunotherapy. Immunotherapy helps your body's immune system fight cancer, but it can sometimes cause your immune system to attack healthy parts of your body, leading to side effects. Researchers will collect blood and stool samples from 200 cancer patients receiving immunotherapy over three years. These samples will be taken at different times during their treatment and follow-up. The aim is to find out why some people get these side effects and others don't, which could lead to better ways to manage or prevent them in the future. This research doesn't involve new medicines; it focuses on understanding current treatments better.

At a glance

Status

Recruiting

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

200

Start

06 Apr 2022

Estimated completion

06 Apr 2028

Oncology

What is this study about?

This research study, known as EXACT, is focused on understanding the side effects that can sometimes happen when people receive immunotherapy for cancer. Immunotherapy is a powerful treatment that helps your own immune system recognise and fight cancer cells. However, sometimes the immune system can become overactive and mistakenly attack healthy parts of your body, leading to what doctors call 'immune-related toxicities' or 'irAEs'. These side effects can affect different organs and parts of your body.

The researchers want to gather information and samples from 200 patients receiving immunotherapy over a period of three years. They will collect blood and stool samples at the beginning of treatment, if side effects develop, during ongoing treatment, and during follow-up. In some cases, if skin-related side effects occur, a small skin sample might also be taken. This detailed collection of samples and clinical information will help the researchers look closely at what might be happening within the body to cause these side effects.

By carefully studying these samples, along with clinical details from your routine care, the hope is to uncover clues about why some people develop these side effects and others don't. Understanding these reasons better could eventually lead to improved ways to predict, prevent, or manage these side effects, making immunotherapy safer and more effective for future patients. This study doesn't involve testing new drugs, but rather deepening our understanding of existing, important cancer treatments.

Key takeaways

Study aims to understand immunotherapy side effects.
No new medicines are involved, just observation.
You provide blood and stool samples at different times.
Helps improve future care for cancer patients.
Participation is voluntary and you can withdraw anytime.

Who may be eligible?

To take part in the EXACT study, you need to be an adult, aged 18 or older. You also need to have been diagnosed with a solid cancer (meaning not a blood cancer) and be planning to start a type of treatment called an immune checkpoint inhibitor, which is a form of immunotherapy. You must be able to understand the study and agree to take part by signing a consent form.

There are some reasons why you wouldn't be able to join. For example, if you have a medical or mental health condition that would stop you from giving informed consent, or if you are already taking part in another drug trial that involves new, investigational medicines. You also can't have already started immunotherapy treatment before joining this study.

Finally, you need to be able to stick to the study schedule, which includes providing samples as requested. The research team will discuss all these points with you to make sure the study is suitable for you.

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?
Do you have a solid cancer diagnosis?
Are you planning to start immunotherapy?
Have you NOT already started immunotherapy?
Are you able to provide regular samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the EXACT study, your participation will largely involve providing samples and allowing researchers to use information from your routine medical care. You will need to provide blood and stool samples at various points: before you start your immunotherapy treatment, during your treatment (especially if you develop side effects), and during your follow-up appointments. If you develop a skin-related side effect, a small skin sample might also be taken.

All other assessments and monitoring of your health and any side effects will be part of your standard care, as decided by your medical team. This study does not involve taking any new medications. The total duration of your involvement will depend on your treatment plan and follow-up schedule, but samples will be collected over a three-year recruitment period from all participants.

Potential risks and benefits

The main potential benefit of joining this study is contributing to important medical research that could help future cancer patients. By helping researchers understand immune-related side effects better, you could be playing a role in developing better ways to manage or prevent these issues, making immunotherapy safer for others. There are no direct personal medical benefits from taking part, as this study focuses on observation and understanding, not direct treatment. The risks associated with participation are generally small and include the minor discomfort or bruising from blood draws, and the inconvenience of providing samples. Any skin biopsies would be a minor procedure with local anaesthetic. You are always free to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Marsden NHS Foundation Trust
Verified postcode
Chelsea, United Kingdom· Recruiting

Common questions

What is immunotherapy?

Immunotherapy is a type of cancer treatment that helps your body's own immune system fight cancer cells more effectively.

What are 'immune-related toxicities'?

These are side effects that can happen when immunotherapy causes your immune system to mistakenly attack healthy parts of your body instead of just cancer cells.

Do I have to take new medicines in this study?

No, this study does not involve giving you any new medicines. It focuses on understanding the effects of your planned immunotherapy treatment.

What kind of samples will be collected?

Researchers will collect blood and stool samples. If you develop a skin-related side effect, a small skin sample might also be taken.

Can I stop participating if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, and it will not affect your medical care.

How to find out more

Laura Boddy

exact@rmh.nhs.uk 020 7352 8171 Official trial record

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