Dear study teams,
We wanted to send a pre-seasonal thank you e-mail regarding recruitment and add a little re scientific plans and progress: Firstly though….
>100 PATIENTS RECRUITED TO SELINA!
Congratulations to our SELINA recruitment sites. We’ve seen a real increase to recruitment rates during the last few months and have recently recruited our 100th patient (target = 250) – now at patient 113. This is a huge milestone for the study so many thanks for your efforts and please keep up the good work!
Recruitment to SELINA is currently due to end on 30/11/2023 but we have submitted a substantial amendment to the sponsor that will extend the end date until December 2024. Please watch out for an email from Emily which will provide more details on this amendment, shortly.
Unfortunately, recruitment to the Pearl study has remained slower over the last couple of months. Only 19/39 sites recruited a patient in October, so we’d again like to encourage a renewed effort in recruitment in the run up to Christmas. Jenni is contacting sites individually to check in, but please do let us know of any particular issues you may be having – we are here to help. As of today, we have recruited 1,392 patients out of a target of 3000.
Site of the Month
Could you be our next ‘Site of the Month’? The teams at King’s, Southampton and Portsmouth have recently received a ‘Thank you’ hamper for recruitment efforts and/or spotting a key missing data field from REDCap. Here is the team in Portsmouth enjoying their hamper 😊
We believe that 2024 will be the year of scientific progress in the DeLIVER program; now that we have samples and clinical data to work with, we have started to send blood samples out for analysis:
- One batch of samples have gone for GAAD/GALAD testing in the Newcastle labs. As many know, this is a serum protein biomarker-based assay (currently in development by Roche) that has been shown to predict the development of hepatocellular carcinoma (HCC) in patients with chronic liver disease. We will eventually send a sample for every participant for GAAD/GALAD testing for both cross-sectional and longitudinal analysis.
- Another batch of “buffy coat samples” (extracted from the cfDNA tubes) will be used in a pilot study to validate DNA extraction methods, before we begin genetic analysis of the DeLIVER patients to see if host genetic polymorphisms can be built into HCC risk algorithms.
- At Oxford, we have making a push to access liver tissue from resection specimens so that we can further assesses the pre-cancerous biology in the cirrhotic liver.
And there is more in the planning…….
We hope to send another newsletter Christmas/new year highlighting new funding/metrics of success re DeLIVER members - so if you have any good news local stories, please do send them to us!
Ellie, Jenni, Emily, James, Andy and Will