RecruitingObservational

Methylation analysis for soft tissue lesions and rapid classification

This study is looking for adult patients who need a biopsy or surgery for a soft tissue lump, possibly a type of cancer called sarcoma. The main goal is to test a new, faster DNA test. Currently, it can take weeks or months to get DNA test results for these lumps, which delays diagnosis. We hope this new test will quickly recognise and classify soft tissue lumps. If successful, this could help doctors diagnose conditions much faster, potentially leading to earlier treatment and better outcomes for future patients. Participants will provide one extra tissue sample during their planned procedure, with minimal additional risk, but will not directly benefit from the results during the study.

At a glance

Status

Recruiting

Sponsor

University of Nottingham

Enrolment target

Start

20 Jun 2025

Estimated completion

30 Jun 2026

Diagnosis of sarcoma in adults

What is this study about?

When doctors need to understand what a soft tissue lump is, they often take a small piece of it, called a biopsy, or remove the whole lump. Then, they look at the cells under a microscope. Sometimes, it can be tricky to tell exactly what it is just by looking at the cells. In these cases, doctors might send off the sample for a DNA test to learn more about its genetic makeup.

The problem is, these DNA tests can take a long time – sometimes weeks or even months – to get the results back. This delay can be very stressful for patients and can slow down when treatment can begin. This study aims to find a much quicker way to get these answers.

We are testing a new special DNA test that we hope will be able to diagnose and classify soft tissue lumps much faster than the tests currently used in the NHS. If this new test works well, it could significantly cut down on the waiting time for patients, which might lead to quicker treatment plans and better overall health outcomes in the future.

Key takeaways

Aims to speed up sarcoma diagnosis using a new DNA test.
Participation involves providing an extra tissue sample during a planned procedure.
No direct personal benefit, but could help future patients.
Results won't guide your current treatment.
Minimal risks, mainly slight extra discomfort during biopsy.
You can withdraw from the study at any time.

Who may be eligible?

You might be able to take part in this study if you are an adult and a doctor thinks you have a soft tissue lump that might be a sarcoma. This means the doctor believes the lump needs to be checked further with a biopsy (where a small piece is taken) or removed completely with surgery.

It's important that you are at least 18 years old and can understand English well enough to follow what's happening and give your permission to be part of the study.

You won't be able to take part if your healthcare team is fairly sure your lump is not serious (meaning it's likely benign, or harmless) based on your medical history, examination, and other tests.

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 an adult (18 years or older)?
Are you able to understand conversations and information in English?
Do you have a soft tissue lump that your doctor thinks might be serious and needs a biopsy or surgery?
Has your medical team not already said that your lump is very likely to be harmless?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the main thing you'll need to do is allow us to collect one extra tissue sample. This sample will be taken at the same time as your planned biopsy or surgery for your soft tissue lump. This means you won't need to make any extra appointments or visits just for this study.

The researchers will use this extra tissue sample for the new DNA test. You won't have to take any special medications or have any additional follow-up appointments related to the study itself. The study is expected to run from July 2025 to June 2027.

Potential risks and benefits

There won't be any direct health benefits for you personally from taking part in this study. However, the information we learn could be really helpful for future patients, potentially leading to faster diagnoses and better treatments for soft tissue lumps. The results from this research test won't be used by your doctors to guide your current care, as it's purely for study purposes at the moment. The risks of taking part are very small, because we're just collecting an extra tissue sample during a procedure you're already having. If you're having a biopsy, you might feel a little more discomfort or pain because the doctor will need to take two extra small samples. You are always free to change your mind and withdraw from the study at any time without it affecting your care.

Locations (3)

Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus
City only
Nottingham, United Kingdom
Nottingham University Hospitals NHS Trust - City Campus
City only
Nottingham, United Kingdom
University of Nottingham
Approximate
Nottingham, United Kingdom

Common questions

What is a soft tissue lump?

A soft tissue lump is an abnormal growth in the soft parts of your body, like muscle, fat, nerves, or blood vessels.

What is a sarcoma?

Sarcoma is a rare type of cancer that can grow in the body's soft tissues or bones.

Will this new test affect my current treatment?

No, the results from this research test won't be used by your doctors to make decisions about your current treatment or care.

Do I have to do anything extra if I join the study?

The only extra step is allowing an additional tissue sample to be collected during your planned biopsy or surgery. No extra appointments are needed.

Can I change my mind after joining?

Yes, you are free to withdraw from the study at any time without it affecting your medical care.

How to find out more

Christopher Deacon

christopher.deacon@nottingham.ac.uk +44 115 82 31113 Official trial record

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