Dear DeLIVER Research Teams,
We’ve now had 3 Teams catch-ups with the DeLIVER sites, it’s been great to see so many of you and hear directly about how the study is going on the ground. Our next catch-up is scheduled for 12pm This coming Thursday 20th June, (where Jenni, Emily, James and myself look forward to updating and answers any queries) – do let Jenni know if you don’t have the invite. Personally, I have really enjoyed putting real faces to the study teams – so thank you to those who have come along.
Pearl
Pearl recruitment has now reached 1770 patients. A fantastic effort! (we are still aiming for 3000). We will shortly be submitting an amendment to extend the recruitment end date to 31st April 2025 which is the current end of the DeLIVER grant. However, we will be applying for an extension to the grant and hope to keep going until at least December 2026.
Follow up visits are now due at all sites who began recruitment prior to December 2022. So far, we have had 325 follow up visits performed, 297 with sample collection and 28 with data only. Many thanks to you all for this.
We do understand that there are times when sample collection is not possible but would like to emphasise how important the samples are to the overall study objectives. If you are unable to collect samples at the follow up visit, then please consider whether it is possible to bring the patient back in for this at a later time. Jenni is always happy to discuss the specifics of individual cases.
Likewise, we thank you for keeping an eye on HCC diagnoses and encourage you to continue checking your MDT lists- this is an absolute study priority. We now have 25 confirmed HCC cases among Pearl participants.
I also want to take an opportunity to give you a heads up regarding the AMULET study – this study aims to evaluate abbreviated MRI vs US for the early detection of HCC. The study is a £2.2million award from NIHR EME, headed up by Michael Pavlides, with Hamish Innes as statistician lead. We will be aiming to recruit 300 patients from DeLIVER sites, including patients with high aMAP scores (at higher risk of HCC). Many of you kindly provided letters of support at application, and Michael will be in the coming days to move forwards with this study. Crucially the first milestone is a feasibility assessment of the ability to recruit to the study (80 patients by next spring/summer), so the pressure will be on us to do just that – thank you for all the enthusiasm shown for this study.
Selina
Recruitment to Selina has been going amazingly well. After a slow start we were concerned about our ability to recruit 250 participants but we are now at 171 so huge thanks to all the sites for your efforts here.
A quick reminder for the SELINA follow up visits; please make sure you are completing a 'routine clinical investigations' form at each follow up visit on REDCap, as well as the 'follow up visit' form.
Amendments:
- Substantial amendment 2 should now have been implemented at all sites. This amendment i) removes the Performance Status and BCLC staging from the eligibility criteria (the small tumour size required for those patients with cirrhosis remains unchanged) and ii) introduced a face-to-face follow up visit.
- The timing of this amendment means we have already missed performing the F2F follow up at 12 months for those participants recruited early on. We are therefore making a further amendment (SA3) to clarify the timing of the face-to-face visit, allowing participants to be brought back at any time after 12 months since the baseline visit. We’d strongly encourage you to invite these participants back and we can offer up to £15 to cover travel expenses.
- Amendment (SA3) also removes the tumour size restriction for patients without cirrhosis. This group of patients often present a more advanced stage of HCC, with larger tumour sizes and we cannot therefore recruit (the anticipated 50 patients) within our existing small tumour size eligibility criteria. Emily will be in touch with further details about this amendment in due course.
Analysis
We’ve been busy sending samples out for analysis. Within the DeLIVER team we have sent over 500 samples for GAAD/GALAD testing and have run preliminary analysis checking for sample quality for genetics and TAPS assays.
100 samples and clinical data have been sent to collaborators in New York looking at evaluation of mutations in cfDNA in liver disease and we are almost ready to send 300 samples to the CRUK Scotland Institute who plan to combine plasma redox-proteomics with machine learning for early detection of hepatocellular carcinoma.
We are also having discussions with a number of other groups about future collaborations.
Sample Manifest
Up to now, we have been shipping frozen samples from sites to Oxford when storage capacity at sites nears capacity. As analysis picks up and specific samples are needed, we will begin to request that samples are sent to us. We ask that a shipping sample manifest is completed and sent to us before shipment . Before arranging the shipment, we check this against the REDCap data and resolve any discrepancies. You should have previously received the manifest but we have made a few updates since the original version- the latest version of the manifest is attached to this e-mail.
We recommend completing the manifest as you collect and process samples rather than waiting until a shipment is due. We ask that data are entered as one row per sample and this can reach into the thousands depending on how large the shipment is. The attached slides give a bit more information on the manifest.
Recruitment graphs
Knowing how much you/we all like data – we attach the recruitment graphs below:
PEARL recruitment
SELINA recruitment
Many thanks to you all, for the on-going efforts to make DeLIVER a success – wishing you a lovely week in the early summer sunshine.
Best Wishes,
Ellie, Jenni, Emily, James and Andy