RecruitingInterventional

A study to find out if a new blood test (microRNA) can be used to monitor people after surgery for seminoma or dysgerminoma cancer

This study, called OTIS-S, is exploring a new blood test that detects tiny genetic signals called microRNA. The goal is to find out if this blood test can effectively monitor people who have had surgery for early-stage seminoma (a type of testicular cancer) or dysgerminoma (a rarer ovarian cancer). Currently, regular scans are used for monitoring, which can be inconvenient and involve radiation. Researchers hope this new blood test could reduce the need for scans, identify if the cancer returns earlier, and potentially lead to less intensive future treatments. It's split into two parts, comparing the new blood test with standard scanning methods.

At a glance

Status

Recruiting

Sponsor

Institute of Cancer Research

Enrolment target

818

Start

15 Mar 2026

Estimated completion

15 Mar 2032

Seminoma and dysgerminoma

What is this study about?

This study is investigating a new and potentially kinder way to keep an eye on people who have had successful surgery for certain types of cancer. These cancers are called seminoma (most common in young men’s testicles) and dysgerminoma (a rarer cancer often affecting young women's ovaries). When these cancers are caught early (Stage I) and removed with surgery, patients usually go on to have regular check-ups with scans like CT, MRI, or ultrasound. These scans help doctors make sure the cancer hasn't come back.

While these scans are very good at what they do, they can be a bit of a burden. They mean lots of hospital visits, and some scans use radiation, which doctors try to limit where possible. This study wants to see if a simple blood test, which looks for tiny genetic markers called microRNA, could be used instead. The hope is that this blood test might be able to spot if the cancer is returning earlier than scans, without the radiation, and be more convenient for patients.

About 1 in 7 people with these early-stage cancers do sadly find their cancer comes back. However, it's usually treated successfully. This research could lead to a new way of monitoring that is easier, safer, and perhaps even more effective at catching any recurrence early, meaning less intensive treatment might be needed down the line.

Key takeaways

New blood test for seminoma/dysgerminoma monitoring.
Aims to reduce the need for frequent scans.
Could detect cancer recurrence earlier.
Study has two parts, comparing blood tests with standard care.
Most participants won't receive direct benefit.
Funded by Cancer Research UK and run in NHS hospitals.

Who may be eligible?

This study is for people who have been diagnosed with early-stage (Stage I) seminoma or dysgerminoma cancer and have recently had surgery to remove it. You would typically have had your surgery within the last 8 weeks, though in some special cases it could be up to 10 weeks.

To be eligible, doctors will need to confirm that your cancer was specifically a 'pure seminoma' type, without other cancer cells mixed in. Also, after your surgery, certain blood markers that were perhaps high before, must have returned to normal levels. You should also not be planning to have any further treatment (like chemotherapy or radiotherapy) straight after your surgery.

There are also some reasons why you might not be able to join. For example, if you've had a similar cancer in your other testicle within the last three years, or if you have other health conditions that might make taking part difficult. Being pregnant would also exclude you. You also need to be willing and able to attend the appointments for the study.

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.

Have you had surgery for Stage I seminoma or dysgerminoma?
Was your surgery within the last 8-10 weeks?
Have your post-surgery blood markers returned to normal?
Are you NOT planning to have further immediate cancer treatment after surgery?
Are you able and willing to attend all study appointments?
Are you NOT currently pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it's divided into two main stages.

In the first stage (Part A), you will continue to have your usual follow-up scans (like CT, MRI, or ultrasound) as your doctors would normally recommend. At the same time, you would also have extra blood samples taken so the researchers can look for the new microRNA markers. This part of the study is expected to last about 2 and a half years, enrolling around 260 people, and everyone will be followed for 5 years after they join.

Once enough information is gathered from Part A and the researchers are happy with the results, the study will move to Part B. In this stage, participants would either have only the microRNA blood tests for monitoring, or only the usual imaging scans. You will be followed for 3 years if you take part in Part B. The study doctors will let you know what is involved and how long you will be taking part before you agree to join.

Potential risks and benefits

For most people taking part, there isn't a direct personal health benefit right now. However, the information gathered is incredibly important and will help improve future care for others with seminoma or dysgerminoma. It's possible the new blood test might help spot if your cancer is coming back earlier, but we don't know for sure yet. Regarding risks, you will still have blood samples taken and imaging scans (like CT or MRI) as you would normally, or perhaps even a PET-CT or X-ray. It's important to know that CT, PET-CT, and X-rays use a type of radiation. While helpful for diagnosis, there's a very tiny chance (about 0.1%) that this radiation could contribute to developing another cancer many years later. This small risk exists whether you join the study or not, as these scans are part of standard care. Apart from this, there are no other expected disadvantages or risks as you'll be receiving your usual care. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (25)

St James' S University Hospital
Approximate
Leeds, England
Worthing Hospital
Approximate
Worthing, England
Northern General Hospital
Approximate
Sheffield, England
The Royal Marsden Hospital
Approximate
London, England
Leicester Royal Infirmary
Approximate
Leicester, England
Velindre NHS Trust
Unverified
Cardiff, Wales
Southampton General Hospital
Unverified
Southampton, England
University Hospitals Bristol and Weston NHS Foundation Trust
Unverified
Bristol, England
Queen Elizabeth Hospital
Unverified
Birmingham, England
Queens Medical Centre
Unverified
Nottingham, England
Lothian
Unverified
City of Edinburgh, Scotland
Poole Hospital
Unverified
Poole, England

Common questions

What is a 'microRNA' blood test?

It's a new type of blood test that looks for tiny genetic signals in your blood, which might show if cancer has returned earlier than other methods.

Why is this blood test better than scans?

Researchers hope it could be more convenient, avoid radiation exposure from some scans, and potentially detect if the cancer is coming back sooner.

Will I still have my regular scans if I take part?

In the first part of the study (Part A), yes, you will still have your regular scans alongside the new blood tests.

How long will I be involved in the study?

Depending on when you join, you could be followed for 3 to 5 years after you enrol in the study.

Will this study benefit me directly?

Not directly for most participants, but the information gained will greatly help improve future diagnosis and care for other patients with these cancers.

How to find out more

Deborah Gardiner

otis-s-icrctsu@icr.ac.uk 442087224057 Official trial record

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