OTIS-S
OTIS-S: Investigating a new blood test for monitoring in testicular and ovarian cancer
Status: In set up
Trial documents (password protected)
What is the study about?
We want to find out if a new blood test can be used to check whether the cancer is returning for people who have had surgery to remove an early stage testicular (seminoma) cancer or a similar type of cancer (dysgerminoma) that normally occurs in the ovaries. Most people have a low risk of their cancer returning after surgery, so they do not need any more treatment and are usually monitored for up to 5 years. Monitoring normally involves check-ups, scans (CT, MRI and/or ultrasound) and blood tests.
OTIS-S will look to see if a new blood test can be used as part of monitoring. Previous research suggests this test might be good at detecting these types of cancer if they are returning. This could reduce or avoid the need for scans which are currently used for this purpose. The blood test may even be able to detect a returning cancer earlier, but this is not yet known.
The study will be conducted in two parts (A and B). Only part A is currently being opened, and this page will be updated once part B is starting.
Who is included in the study?
OTIS-S includes people with early testicular (seminoma) cancer or ovarian (dysgerminoma) cancer. Everyone who joins the trial will have had surgery to remove their cancer and have a low risk of the cancer returning. Up to 260 people will be included in part A from NHS hospitals across the UK.
What does the study involve?
People who join the OTIS-S study in part A will have the new blood test alongside the normal monitoring, which involves check-ups, scans (CT, MRI and/or ultrasounds? and blood tests.
Everyone will have regular check-ups for 5 years to check if the cancer is returning and we will collect information about how they are getting on until the study is completed.
Further information for participants
Participant information sheet - PART A - Adults
Participant information sheet - PART A - Parent and Guardian
Participant information sheet - PART A - Older Children and Younger teenagers
Participant information sheet - PART A - Children
A detailed summary will be available on Cancer Research UK’s website (link to be provided once the record is live)
Our team are unable to offer any medical advice. If you are interested in finding out more about the trial or the tests involved, please talk to your hospital doctor or GP about whether they may be a suitable option for you.
Further information for healthcare professionals
Contact details and regulatory information
Chief Investigator: Doctor Alison Reid, Royal Marsden NHS Foundation Trust
Senior Clinical Coordinator: Professor Robert Huddart, Royal Marsden NHS Foundation Trust
ICR-CTSU Methodology Lead: Doctor Fay Cafferty
Trial management contact: [email protected]
Sponsor: The Institute of Cancer Research
Funding: Cancer Research UK – Cancer Research Committee Clinical Trial Award - CRUK/24/008
Trial identifiers
REC reference: 25/LO/0836
CPMS ID: 61831
ISRCTN registry: TBA