The Prospective Ocular Melanoma Natural History (OMNi) Study
Research type
Research Study
Full title
A Prospective Natural History Study in Uveal Melanoma.
IRAS ID
283448
Contact name
Joseph Sacco
Contact email
Sponsor organisation
University of Liverpool
Clinicaltrials.gov Identifier
AAAR5976, International Protocol Reference; 29/03/2019, International Protocol Date; SSOMNI_D014, UK Regional Regulatory Appendix Reference; 1.0, UK Regional Regulatory Appendix Version; 24/11/2021, UK Regional Regulatory Appendix Date
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Uveal Melanoma (UM) is the most common primary inner eye cancer in adults, accounting for 85-95% of all eye cancer cases; but representing only about 3-5% of all melanoma types. While a recent trial has shown that treatment with tebentafusp leads to an improvement in survival, it is only effective in patients with the HLA A*0201 genotype(<50% of the population) and progression appears to ultimately occur in all patients. Other treatment options show some promise in treating this disease but none are as yet proven to improve survival. There is therefore an urgent need to develop novel therapies in the treatment of UM.
The Prospective Ocular Melanoma Natural History (OMNi) Study will develop a research database, known as the OMNi Database, which will collect medical and scientific data on the treatment and management of patients diagnosed with UM. This will allow us to gain a better understanding of UM, the effects of existing drugs, help guide the development of new agents and improve the design of future studies.
Adults diagnosed and living with UM will be recruited from NHS sites across the UK. Patients who are enrolled on to the OMNi Study will not receive any study-specific treatment or intervention and their normal treatment or management for UM will not be impacted. All data that is collected for the OMNi Study will be retrieved from a range of sources including hospital records, patient medical records or via direct contact with patients.
The OMNi Study is funded by Immunocore LLC (USA). The OMNi Database is hosted and maintained by Pulse Infoframe Inc (Ontario, Canada). The OMNi Study is an international collaboration between the Liverpool Clinical Trials Centre (University of Liverpool, UK), Columbia University Irving Centre (USA) and the Australia and New Zealand Melanoma Trials Group.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
22/NW/0020
Date of REC Opinion
18 Jan 2022
REC opinion
Favourable Opinion