OTIS - S

• Research type

  Research Study

• Full title

  A phase II/III trial evaluating use of circulating serum miRNA as part of active surveillance for patients with stage I seminoma and dysgerminoma

• IRAS ID

  342479

• Contact name

  Alison Reid

• Contact email

  Alison.Reid@rmh.nhs.uk

• Sponsor organisation

  The Institute of Cancer Research

• Duration of Study in the UK

  9 years, 0 months, 0 days

• Research summary

  Why is the study being done?
  We want to find out if a blood test that detects circulating microRNA (miRNA) could be used to detect if a patient’s cancer has returned.
  Testicular seminoma is one of the commonest cancers in young men; ovarian dysgerminoma is rarer, typically affecting teenagers/young adults. Stage I disease is well managed with surgery followed by surveillance using imaging (CT or MRI, or ultrasound for younger dysgerminoma patients) but this is a burden for patients, may expose them to harmful radiation, and is costly for the NHS. Approximately 15% of these patients will have their cancer come back but this is usually treated successfully.
  miRNA shows significant promise as a blood-based marker detecting if a patient’s cancer is returning. It might reduce the need for imaging and even bring relapse detection forward, reducing the need for subsequent intensive treatments.

  What is being tested?
  OTIS-S is split into two parts. In part A people who join OTIS-S will have their blood to see if any miRNA can be detected, alongside the regular imaging they would have as standard of care. Once the trial has enough data and we are satisfied with the results the study will move on to part B where patients will have either miRNA blood tests only or imaging only.

  Who can join the study?
  OTIS-S aims to have a total of 818 people with early (stage I) seminoma or dysgerminoma who have undergone surgery and are planned for surveillance join the study. Part A will aim to recruit 260 people and Part B 518 people.

  Where is the study taking place?
  OTIS-S is taking place at multiple NHS sites across the United Kingdom.

  How long will the study last?
  OTIS-S is expected to take nine years in total, with all patients being followed up for up to five years after they enter the study.

• REC name

  London - South East Research Ethics Committee

• REC reference

  25/LO/0836

• Date of REC Opinion

  22 Dec 2025

• REC opinion

  Further Information Favourable Opinion