Not yet recruitingOBSERVATIONAL

LATe TreatmENT Related Toxicity in Melanoma (LATENT)

This study, called LATENT, is investigating the long-term side effects of modern immunotherapy treatments for advanced melanoma. While these treatments have greatly improved survival, some patients experience side effects that can last for years, and we don't know enough about them. Researchers will confidentially look at existing medical records of about 400 patients who have had a lasting positive response to immunotherapy for at least three years. They will collect information on how often these side effects occur and how severe they are. The goal is to better understand these long-term issues, so that healthcare teams can develop improved support and care plans for patients living well after treatment.

At a glance

Status

Not yet recruiting

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

400

Start

01 Dec 2024

Estimated completion

01 Dec 2024

Melanoma

What is this study about?

This study is called LATENT, which stands for LATe TreatmENT Related Toxicity in Melanoma. In simple terms, it's about understanding the long-term effects of treatments for advanced melanoma. Melanoma is a serious type of skin cancer, and over the past few years, we've seen fantastic progress with new medicines called immunotherapies. These treatments help your body's own immune system fight the cancer, and they have greatly improved how long people live with advanced melanoma.

While these treatments are very effective, they can also cause side effects. We know about the short-term side effects that many patients experience during treatment. However, because more people are now living longer after treatment, doctors are realising that some patients experience side effects that last for years — these are the 'late-term' effects. At the moment, we don't have enough clear information about how often these long-term side effects happen, how serious they are, or how they affect people's daily lives.

That's why this study is so important. Researchers from leading hospitals like Clatterbridge and Christie's are working together to look back at the medical records of around 400 patients. They will specifically focus on patients who have had advanced melanoma, received immunotherapy, and have responded well to treatment for at least three years. By carefully reviewing these records, the team hopes to build a clearer picture of these late side effects. The information they gather will help doctors provide better, more tailored care and support for patients living well after immunotherapy, making sure any long-term issues are properly managed.

Key takeaways

This study investigates long-term side effects of immunotherapy for advanced melanoma.
It uses existing, anonymised medical records, so no direct patient involvement is needed.
Focuses on patients who had a good, lasting response to treatment (at least 3 years).
Aims to improve future patient care and support for those with long-term side effects.
Your personal details will be kept completely confidential and made anonymous.

Who may be eligible?

This study is looking at information from medical records of people who have already been treated for melanoma. To be included, the original diagnosis must have been melanoma, and the person must have been 18 years or older when they received treatment.

They would have been treated for advanced melanoma (meaning the cancer had spread or was difficult to remove surgically) between January 2005 and December 2020. The treatment they received must have been one of the specific immunotherapy drugs like Pembrolizumab, Nivolumab, Ipilimumab, or a combination of these. Importantly, they must have had a good, lasting response to this treatment for at least three years.

You would not be included if you had other active cancers needing treatment at the time, or if your immunotherapy was only for early-stage melanoma, or if you received other main treatments after immunotherapy. Also, if your melanoma got worse during or after immunotherapy, your records would not be used for this particular study, as the focus is on long-term responders.

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.

Did you have a melanoma diagnosis?
Were you 18 or older when treated?
Did you receive immunotherapy for advanced melanoma between 2005-2020?
Did you respond well to treatment for at least three years?
Did you not have other active cancers needing treatment at the time?

Answer every question to see your result.

What does participation involve?

You won't actually be asked to do anything for this study. Because it's an 'observational' study, researchers will simply look at information that is already in your past medical records. This means there are no extra hospital visits, no new tests, no treatment changes, and no follow-up appointments for you specifically related to this study. Your care will continue as normal. Your medical data will be kept private and anonymised, meaning your name and other identifying details will be removed so the researchers can't tell who you are.

Potential risks and benefits

There are no direct risks to you from taking part in this study because you will not be undergoing any new procedures or treatments – only your existing, anonymised medical records will be reviewed. The main benefit is to future patients. By better understanding the long-term side effects of melanoma immunotherapy, this study aims to improve the care and support available for people living well after their treatment. This could lead to better management plans and specialist services. Because your data is anonymised, you don't need to do anything if you prefer not to participate; if your medical records meet the criteria, the anonymised data may be used.

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

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 'long-term side effects'?

These are health problems or symptoms that people experience for many months or even years after their cancer treatment has finished.

Will my personal details be safe?

Yes, absolutely. The researchers will remove all personal details from your medical records before they study the information, so you cannot be identified.

Do I need to do anything to be part of the study?

No, you don't need to do anything. Researchers will use existing, anonymised information from medical records if it fits the study criteria.

How will this study help patients?

By understanding more about long-term side effects, doctors hope to create better support and care plans for patients living well after melanoma immunotherapy.

How to find out more

Arjun Modi

arjun.modi@rmh.nhs.uk 020 7352 8171 Official trial record

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