Not yet recruitingObservational

Investigation of the diagnostic accuracy of a new blood test for endometriosis, compared with the current gold standard surgery for diagnosis

Endometriosis occurs when tissue similar to the womb lining grows outside the womb, causing pain and other symptoms. At present, the main way to confirm a diagnosis is through keyhole surgery (a laparoscopy). However, up to half of women who undergo this procedure find out they do not have the condition. This clinical study is evaluating a new blood test called the Mitomic® Endometriosis Test (MET™). The goal is to see if this test can detect endometriosis accurately without the need for an operation. Taking part will not change your planned care. If you are already scheduled for your first diagnostic keyhole surgery, you will simply provide an extra blood sample during your routine pre-op tests. You will also fill out a symptom survey and a recovery diary. Findings could help future patients receive a quicker diagnosis without surgery.

At a glance

Status

Not yet recruiting

Sponsor

MDNA Life Sciences

Enrolment target

600

Start

01 Jan 2027

Estimated completion

01 Jan 2028

Endometriosis

What is this study about?

Endometriosis is a common condition where tissue resembling the lining of the womb grows in other areas of the body, such as the ovaries and fallopian tubes. It can cause severe pelvic pain, heavy periods, and difficulty getting pregnant. Because its symptoms often match other conditions, doctors usually have to carry out a keyhole operation, known as a laparoscopy, to look inside the tummy and confirm the diagnosis. For many women, this means waiting a long time for surgery, only for about half of them to find out they do not have endometriosis after all.

Researchers are testing a new blood test called the Mitomic® Endometriosis Test (MET™). This study wants to find out whether the blood test can identify endometriosis just as reliably as surgery. If it works, the test could help people get diagnosed and treated much faster, while saving many others from having an unnecessary operation.

By taking part, you will help researchers compare the blood test results directly against what the surgeon sees during your planned operation. The study aims to recruit 600 women across the UK to generate strong evidence for the NHS. This could change how endometriosis is diagnosed in the future.

Key takeaways

Tests a new blood test (MET™) designed to diagnose endometriosis without surgery.
Open to women waiting for their first keyhole surgery to investigate suspected endometriosis.
Requires only one extra blood sample, a symptom survey, and a post-op recovery diary.
Your planned surgery and medical care will remain completely unchanged.
Helps researchers gather evidence to potentially bring a simple blood test to the NHS.

Who may be eligible?

You may be able to take part if you are female, have started having periods, have not yet reached the menopause, and are already booked in for your very first keyhole surgery (laparoscopy) to check for suspected endometriosis.

To join, you must be happy to give an extra blood sample during your normal hospital visit before your operation, and be well enough to have the surgery as planned.

You will not be able to join if you have already been diagnosed with endometriosis through surgery in the past, if you cannot have general anaesthetic, or if you are taking antibiotics or have taken them within the last two weeks.

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.

I am female and have started my periods, but have not gone through menopause.
I am scheduled to have my first keyhole surgery (laparoscopy) to look for endometriosis.
I have never been diagnosed with endometriosis through surgery before.
I have not taken any antibiotics in the past two weeks.
I am willing to donate an extra blood sample before my operation.

Answer every question to see your result.

What does participation involve?

Taking part will not alter your planned medical treatment or delay your operation. During your standard pre-operation hospital visit, a nurse will take one extra blood sample at the same time as your routine blood tests. Your keyhole surgery will go ahead exactly as planned, and your surgical team will record their normal findings.

You will also be asked to complete a short questionnaire describing your symptoms and keep a simple diary at home to track your recovery after the operation. Your blood test result will not be used to guide your personal treatment, so you will receive the exact same standard of care from your doctors. The study is due to run from January 2027 to May 2028 across roughly 12 hospital sites.

Potential risks and benefits

Taking part will not directly improve your personal health or change your treatment, but your participation could help future patients get a faster diagnosis without needing an operation. The physical risks of joining are very low. The only extra medical step is giving a small blood sample, which is usually done at the same time as your routine pre-op bloods, though it may cause minor bruising or brief discomfort. Taking part is completely voluntary. You are free to withdraw from the study at any time without giving a reason, and this will never affect the standard of care or treatment you receive from the NHS.

Locations (12)

Birmingham Women's Hospital
Unverified
Birmingham, England
Colchester General Hospital
Unverified
Colchester, England
Burnley General Teaching Hospital
Unverified
Burnley, England
University College Hospital
Unverified
London, England
Southmead Hospital
Unverified
Bristol, England
Hampshire Endometriosis Centre
Unverified
Southampton, England
East Surrey Hospital
Unverified
Redhill, England
Queen Elizabeth University Hospital
Unverified
Glasgow, Scotland
Scunthorpe General Hospital
Unverified
Scunthorpe, England
University Hospital Wales
Unverified
Cardiff, Wales
Royal Infirmary of Edinburgh
Unverified
Edinburgh, Scotland
Liverpool Women’s NHS Foundation Trust
Unverified
Liverpool, England

Common questions

Will taking part delay my planned surgery?

No. Your keyhole operation will go ahead on its scheduled date. The extra blood sample is collected beforehand, usually during your routine pre-operative visit.

Will the blood test results change my treatment?

No. The blood test is purely for research. Your medical team will base all your care and treatment on what they see during your surgery, just as they normally would.

Does the study involve extra hospital visits?

No extra hospital appointments are needed. The sample is taken during your existing visits, and questionnaires can be filled in at home.

What happens if I change my mind?

You can leave the study at any point. Deciding to withdraw will have no effect on your operation, your relationship with your doctors, or your NHS care.

Who is paying for and running this study?

The study is funded and sponsored by MDNA Life Sciences, the company that developed the new blood test.

How to find out more

Harry Smart

h.smart@mdnalifesciences.com +44 (0)7768 333 371 Official trial record

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