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Enrolling by invitationOBSERVATIONAL

SMS 2: Impact of Cancer Therapy on the Somatic Mutational Landscape of Normal Tissues

This study, called SMS 2, explores how cancer treatments, such as chemotherapy, radiotherapy, or newer targeted drugs, might affect the tiny changes (mutations) that naturally happen in our healthy cells over time. Researchers at the Wellcome Sanger Institute can now spot groups of cells with these mutations. We want to see if the treatments change the number or type of these mutated cell groups in cancer patients. To do this, we'll collect small samples like blood, cheek swabs, and urine from adult cancer patients receiving these treatments. We may also use leftover tissue from any surgery you might have as part of your care. This research helps us understand more about how treatments affect healthy parts of the body.

At a glance

Status
Enrolling by invitation
Sponsor
The Wellcome Sanger Institute
Enrolment target
60
Start
26 Nov 2024
Estimated completion
13 May 2029

What is this study about?

You might be wondering what this study is all about. Our bodies are made of billions of tiny building blocks called cells. Over time, these cells can develop small changes in their genetic code, almost like tiny typos. These changes are called mutations, and they're quite normal, happening throughout our lives. Things like sunlight, smoking, or just the natural process of cells dividing can cause them.

Recently, scientists have developed new ways to find groups of cells that have these mutations, even in healthy parts of the body. In this study, we want to understand how different cancer treatments – like chemotherapy, radiotherapy, immunotherapy, or specific targeted drugs – might affect these groups of mutated cells. Do the treatments change how many there are? Do they change the types of mutations we see? By finding this out, we hope to learn more about how cancer treatments interact with healthy parts of your body.

To do this, we'll ask for some simple samples, such as blood, a swab from the inside of your cheek, and a urine sample. If you have surgery as part of your treatment, we might also ask to look at any tiny pieces of tissue that are left over and would otherwise be thrown away. Your participation is really important because it helps scientists understand more about cancer and its treatments, potentially leading to better care in the future.

Key takeaways

  • This study helps understand how cancer treatments affect healthy body cells.
  • It involves simple sample collection: blood, cheek swabs, and urine.
  • Participation will not change your medical care or treatment plan.
  • There are no direct personal benefits, but it helps future patients.
  • You can withdraw from the study at any time without any consequences.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over. You should be planning to start cancer treatment that affects your whole body (like chemotherapy), or radiotherapy or immunotherapy, at one of the hospitals involved in the study. You also need to be able to understand what the study involves and agree to take part, and be able to give the required samples.

There are some reasons why you might not be able to join. For example, if you don't speak English well enough to understand the study information, or if you can't give your agreement to take part. Also, if you know you have Hepatitis B, Hepatitis C, or HIV, you won't be able to participate. We also need to make sure you're likely to continue your treatment for at least three months.

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.

  1. Am I 18 years old or older?
  2. Am I about to start cancer treatment (like chemo, radiotherapy, immunotherapy)?
  3. Can I give blood, cheek swab, and urine samples twice?
  4. Do I understand what the study is about and agree to take part?
  5. Do I expect to continue my treatment for at least 3 months?
Answer every question to see your result.

What does participation involve?

If you decide to take part, we would ask you to provide a few simple samples during your routine care. This would involve a small blood sample, a swab from the inside of your cheek (a bit like a large cotton bud), and a urine sample. You would be asked to provide these samples on two separate occasions as part of your standard clinic visits. We would also discuss the study with you and make sure you understand everything before you agree to participate. The total duration of your participation would depend on your treatment plan, but we are looking for patients likely to complete at least three months of treatment.

Potential risks and benefits

There are no direct personal health benefits for you from taking part in this study. However, the information we collect could help scientists better understand how cancer treatments affect the body, which might lead to improved treatments for future patients. The risks are very low, mainly just the minor discomfort of having a blood test. You are free to change your mind and withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Wellcome Sanger Institute
    Verified postcode
    Cambridge, United Kingdom

Common questions

What are 'mutations'?

Mutations are tiny, natural changes in the genetic code of your cells, like small typos that happen over time.

Will taking part affect my cancer treatment?

No, taking part in this study will not affect your cancer treatment in any way. You will still receive your standard care.

What happens to my samples?

Your samples will be used by researchers at the Wellcome Sanger Institute to study the genetic changes in cells.

Do I have to pay to be in the study?

No, there are no costs to you for taking part in this study.

Can I leave the study at any time?

Yes, you are free to leave the study at any time, for any reason, without affecting your medical care.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "SMS 2: Impact of Cancer Therapy on the Somatic Mutational La…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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