LATENT V1.0
Research type
Research Study
Full title
LATe TreatmENT related Toxicity in Melanoma (LATENT)
IRAS ID
332820
Contact name
Kate Young
Contact email
Sponsor organisation
The Royal Marsden hospital
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Recent improvements in advanced melanoma treatment with immunotherapy have dramatically improved patient survival. Longer survival however has come at a cost of toxicity. Short term side effects can occur in >50% of patients undergoing immunotherapy treatment; however, many long-term survivors are also living with serious consequences of these treatments which may be under reported in literature.
Data regarding long term toxicities, from these treatments is lacking and an area of important unmet clinical need. Therefore, in collaboration with the Clatterbridge and Christie’s teams, we propose to retrospectively analyse the nature, incidence, frequency, and severity of immune related toxicities in around 400 patients who received immunotherapy for advanced melanoma with ongoing durable responses to treatment of at least 3 years.
We will set up a collective anonymized database and record this information through review of electronic medical records of patients that meet the eligibility criteria. We will also review the patterns of use of long-term immunosuppression and assess the need for specialist referrals for managing late side effects.
We hope that this data will help us address gaps in the management of long-term survivors by identifying areas of need and establishing a coordinated evidence based multidisciplinary service to provide personalised, risk stratified long term follow up.
REC name
Wales REC 3
REC reference
24/WA/0225
Date of REC Opinion
29 Jul 2024
REC opinion
Further Information Favourable Opinion