RecruitingObservational

Development of a blood test for uterine sarcoma - diagnosis

This study is trying to create a new blood test to better diagnose womb cancers called uterine sarcomas. These cancers are rare but can be tricky to identify because their symptoms and scan results often look very similar to common, harmless growths called uterine fibroids. Current tests don't always pick up these cancers early enough. Researchers are investigating if a new blood test, which looks for tiny pieces of cancer DNA in the blood (called ctDNA), can help. They want to see if this test can tell the difference between uterine sarcomas and fibroids before surgery. If successful, this could lead to faster, more accurate diagnoses for people with suspected womb problems in the future.

At a glance

Status

Recruiting

Sponsor

University of Leicester

Enrolment target

Start

01 Jul 2025

Estimated completion

01 Mar 2028

Uterine sarcomas and uterine fibroids

What is this study about?

This research project is focused on developing a new type of blood test to help doctors diagnose womb cancers, known as uterine sarcomas, more accurately. These cancers are quite rare, affecting about 3 in every 100 people with womb-related cancers. The main challenge is that their symptoms and how they look on scans are very similar to uterine fibroids, which are harmless growths. This often makes it hard for doctors to tell them apart without surgery, and current biopsy methods only find about a third of these cancers.

The study aims to use a technique that looks for tiny fragments of cancer cells, called circulating tumour DNA (ctDNA), in a blood sample. Cancer cells release these fragments, and their unique genetic make-up might give clues about whether cancer is present. Right now, there isn't a specific blood test to help doctors and patients decide if a growth is a sarcoma or a fibroid. By studying these tiny DNA fragments, the researchers hope to find clear differences between uterine sarcomas and fibroids.

The main goal is to test whether this new ctDNA blood test can accurately identify people who have a uterine sarcoma and those who don't. If successful, this could mean that in the future, people with suspected womb problems might have a simple blood test that helps doctors make a quicker and more confident diagnosis, potentially leading to better and earlier treatment decisions.

Key takeaways

Developing a new blood test for womb cancer diagnosis.
Aims to tell the difference between cancer (sarcomas) and harmless growths (fibroids).
Uses tiny DNA fragments found in blood (ctDNA).
Participation involves giving an extra blood sample before surgery.
Your involvement could help future patients greatly.

Who may be eligible?

This study is looking for women who are between 18 and 99 years old.

You can take part if you are already scheduled to have surgery on your womb because doctors suspect you might have a uterine sarcoma, or if you have a fibroid that looks unusual.

You cannot take part if you are not having surgery for these reasons, are male, or are unable to understand the study requirements even with help.

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 female?
Are you between 18 and 99 years old?
Are you scheduled for womb surgery due to suspected uterine sarcoma or an unusual fibroid?
Are you willing and able to understand and agree to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, we will collect information from tests you're already having before your surgery. This includes your scan images (like ultrasound, MRI, or CT scans), results from your regular blood tests, and any biopsies taken from the lining of your womb. Before your planned surgery, a special blood sample will be taken specifically for this study. This blood sample will be checked for the tiny DNA fragments that the researchers are studying. The results from your blood sample will then be compared with what is found during your surgery.

Some participants will also be asked if they'd like to have an interview. This interview is a chance to share your thoughts and feelings about being part of the study and what you think about the idea of a blood test for diagnosing uterine sarcomas. The study is expected to run from April 2025 to March 2028.

Potential risks and benefits

It's important to know that you're unlikely to notice any direct health benefits from taking part in this specific study. Your doctors will continue to provide the best care for you based on current practices. However, your involvement is extremely valuable because the information gathered could greatly help other patients in the future who are suspected of having a uterine sarcoma. The main risk involved is the extra blood sample, which is a standard procedure and generally very safe, though you might feel a brief sting or have a small bruise. Remember, you can choose to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

University Hospitals of Leicester NHS Trust
City only
Leicester, England

Common questions

What is a uterine sarcoma?

A uterine sarcoma is a rare type of cancer that starts in the womb (uterus). It's different from more common womb cancers.

What is a uterine fibroid?

A uterine fibroid is a very common, non-cancerous growth that develops in the womb. They are usually harmless but can sometimes cause problems.

What is 'ctDNA'?

ctDNA stands for 'circulating tumour DNA'. These are tiny pieces of genetic material released from cancer cells that can be found in your blood.

Will I get my test results from the study?

The study is developing a new test, so the results won't directly affect your current care. Your doctors will continue to use standard diagnostic methods.

Who is paying for this research?

This study is being funded by The Eve Appeal, a UK charity that supports research into gynaecological cancers.

How to find out more

Esther Moss

leicestergcrg@le.ac.uk - Official trial record

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