PerceIVe
Research type
Research Study
Full title
Power of liquid biopsy tracking in immunotherapy treated stage III and IV melanoma (PerceIVe)
IRAS ID
344721
Contact name
Arjun Modi
Contact email
Sponsor organisation
The Royal Marsden Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
CCR6083, CCR6083
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The advent of immune checkpoint inhibitors has remarkably improved survival in advanced melanoma patients in the last decade. Long term responders following cessation of immunotherapy after completion of 2 years of treatment or earlier due to toxicities go on to surveillance with frequent radiological imaging 3-6 monthly up to 5-10 years. This not only exposes patients with a relatively low risk of recurrence to significant amounts of ionising radiation, but also increases the burden and cost on already stretched radiology departments.
ctDNA, a form of DNA released by cancer cells into blood circulation has been studied and shown to have a role in detection, prognostication and correlation with tumour burden to assist with making treatment decisions across several cancers. While there is ongoing research into ctDNA in early stages of melanoma, there is very limited data on its role in detecting relapse or progression of disease in the advanced stages for patients on surveillance. Therefore, this study aims to assess the feasibility of using ctDNA for detecting disease relapse or progression at the
point of radiological progression. We will also assess patient satisfaction of using ctDNA analyses through a simple survey.
100 patients will be recruited over 12 months from multiple centres across the UK that treat high volume melanoma patients, at point of disease progression. We will collect biological samples including a routine plasma blood test, a finger prick and a urine sample which will be transferred to 4 relevant labs where they will undergo analyses. These include:
- Plasma ctDNA (Manchester)
- Finger prick blood spot ctDNA (Cambridge)
- Urine cfDNA (Cambridge)
- Immunophenotyping (IMUBiosciences)
We hope that data from this pilot study will help to design a future validation study for establishing the optimal liquid biopsy for surveillance in advanced melanoma patients and streamline the surveillance process for our patients in the future.REC name
West of Scotland REC 5
REC reference
24/WS/0161
Date of REC Opinion
21 Nov 2024
REC opinion
Favourable Opinion