Dear DeLIVER Research Teams and PIs,
Welcome to Newsletter 16 – sorry it’s a long one!
The Pearl Study
Recruitment to date: 1963/3000
Follow up visits completed: 612
HCC diagnoses to date: 42
Recruitment and Follow Up Progress
We’ve recently seen a slow down in recruitment, likely due to the increased focus on follow up visits. These follow up visits are continuing at pace with 612 already completed and another 450 due over the next few months. Follow up visits and sample collection are vital to the success of the study so we’re immensely grateful for every single one.
We do have some overdue follow up visits. Please work to bring participants back for these visits as soon as possible. If you are unable to coincide these with a clinic visit, we can reimburse up to £15 for travel expenses for research-only visits.
To reach our target of 3000 participants, we need a renewed push in recruitment. Currently, we have 43 sites open and recruiting with another 3 in various stages of set up. If each site could aim to recruit just 4 participants per month, we’d be on track to reach our target by next April. While some sites consistently meet or exceed this rate (thank you!) we hope it is an achievable target for most. Every additional participant brings us closer to our study objectives, and we’re grateful for each new recruit.
The sample size for the Pearl study was calculated with the expectation that at least 100 participants would go on to develop HCC. Early recruitment remains key, as it maximises follow up time and increases our ability to collect samples if and when an HCC diagnosis arises.
Jenni will be reaching out to provide each of you with an individual update on recruitment and follow up. In the meantime, please feel free to contact us with any questions.
The Selina Study
Recruitment: 215
Follow up visits: 84
Thanks to your tremendous efforts we have now recruited 215 participants to the Selina study! The total recruitment target for Selina is 250 so we are now within touching distance of this.
While we encourage you to continue recruiting participants with cirrhosis, we ask that you to now focus your efforts on recruiting participants who do not have a diagnosis of cirrhosis – there are 20 such participants currently in the cohort and we are aiming for a total of 50.
Following the recent protocol amendment, eligibility criteria for these participants have been adjusted, with key points summarised below. Please contact Emily with any questions regarding these criteria:
- Diagnosed with any size HCC and without cirrhosis (see Appendix C of the protocol for Radiological Guidelines for characterisation of HCC)
- Diagnosis of HCC shown or confirmed within 3 months prior to enrolment
- Patients with a diagnosis of HCC that was fully ablated or resected more than 6 months ago and now presenting with a new diagnosis of HCC in a different site in the liver may be included in the study
- Histological confirmation is required to establish the diagnosis of HCC in patients without cirrhosis (imaging alone is not considered sufficient to establish the diagnosis of HCC).
Freezer & Sample Storage
Good news! We have secured funding and space for two new -80°C freezers (from NIHR), which we expect to have operational by the end of the year. We appreciate your patience while waiting for sample shipments, and we’ll work through pending requests as soon as we can.
The DeLIVER analytics team has been meeting regularly to prepare for upcoming analyses. We will soon be needing a sample for every Selina participant, along with 2 matched control patients from the Pearl cohort for analysis. Many of these samples remain at sites around the country so we’ll be in touch to begin having these shipped to Oxford, while also trying to avoid immediately filling our new freezers!
Volunteer newsletter – watch this space
Just to let you know – we are working to develop a newsletter for patient volunteers this month, really a thank you and an update to patients – we will discuss at our site catch up the best way to disseminate this to our volunteers and likely ask a few of the teams to give us feedback before we send out.
Next DeLIVER sites catch up – this week!
Thank you all for your commitment to the success of both the Pearl and Selina studies and we hope to see many of you at the next DeLIVER sites catch up meeting this Thursday 7th November at 12pm (please contact Jenni if you do not have the link). These are short and fun (for a study catch up😊) so hope to see you there,
Kind regards,
Jenni (pearl study coordinator), Emily (Selina study coordinator), Ellie (CI) and James (all things data)