Dear study teams,
We hope you have all had a good summer, managed to enjoy some time away from work, and survived the mini heat-wave last week.
As expected, recruitment to Pearl and SELINA has slowed down over the summer months but we’re hopeful this will pick up again as we settle into Autumn. Please do let us know if you have any particular issues around recruitment or capacity at site and we’ll do what we can to help. Although still a way to go, we are delighted that we now have 84/250 patient recruited into the SELINA study and 1268/3000 patients into the Pearl study - the uptake in recruitment to the SELINA study is great news. So thank you all (do scroll on down to the recruitment tables and graphs below).
Whilst the major focus has been on set up and recruitment I do hope we can start to move in earnest into the areas of scientific enquiry using the samples and clinical data to support HCC detection and risk stratification, and hopefully in the next newsletter I can update you more on that, so that you can see how we are really putting this to good use. But for now more details on the Pearl substantial amendment:
Pearl Substantial Amendment
Substantial amendment 2 has now passed the 35-day deadline and should be implemented at all sites.
The main change to be aware of is the extension of the follow up visit window from 12 months to 18 months. There has been no change to the procedures required at the follow up visits so please continue to collect data and samples as previously.
Patients who have already had their first follow up visit
Please book the second follow up 18 months (+/-3 months) after the date of their first follow up, i.e., 2 ½ years from baseline. Subsequent visits should take place every 18 months.
Patients who already had a follow up appointment booked at the time of the amendment
You may either continue with the planned visit or cancel and rearrange for 18 months from the date of the baseline visit. Future follow up visits should take place 18 months from the date of the previous follow up visit
Patients not due follow up yet or no appointment booked
Please book the first follow up visit for 18 months (+/-3 months) from the baseline visit date, and every 18 months after that
HCC Diagnosis
We are still asking that as and when participants are diagnosed with HCC, an unscheduled visit takes place with sample collection prior to treatment for the HCC.
This amendment will mean putting a pause on follow up visits for many of you so we’d like to ask that you focus again on recruitment to the study. We have extended the recruitment end date to 31st July 2024 but will need all your efforts if we are to reach our recruitment target by then. Although we have recruited >1250/3000 participants – an excellent achievement, there is still a long way to go.
We’d be delighted if you can over-recruit where possible and are very grateful to those of you who have continued recruiting beyond your target.
As ever do get in touch if we can help resolve any local issues, or if anything unclear.
PEARL recruitment update
|
Site |
PI |
mNCA Status |
C&C Approved |
SIV |
Green Light Issued |
First Patient Recruited |
No. Patients Recruited |
|
Oxford |
Emma Culver |
Fully Executed |
Yes |
Performed |
Yes |
23/02/2022 |
121 |
|
Hull |
Lynsey Corless |
Fully Executed |
Yes |
Performed |
Yes |
24/03/2022 |
55 |
|
Plymouth |
Matthew Cramp |
Fully Executed |
Yes |
Performed |
Yes |
13/04/2022 |
71 |
|
St George's |
Dan Forton |
Fully Executed |
Yes |
Performed |
Yes |
26/04/2022 |
63 |
|
Kings |
Kosh Agarwal |
Fully Executed |
Yes |
Performed |
Yes |
29/04/2022 |
80 |
|
Bradford |
Sulleman Moreea |
Fully Executed |
Yes |
Performed |
Yes |
11/05/2022 |
16 |
|
C&W - West Middlesex |
Matthew Foxton |
Fully Executed |
Yes |
Performed |
Yes |
11/05/2022 20/09/2022 |
43 7 |
|
Brighton |
Sumita Verma |
Fully Executed |
Yes |
Performed |
Yes |
13/05/2022 |
11 |
|
Middlesbrough |
Darren Craig |
Fully Executed |
Yes |
Performed |
Yes |
26/05/2022 |
63 |
|
Imperial |
Nowlan Selvapatt |
Fully Executed |
Yes |
Performed |
Yes |
30/05/2022 |
30 |
|
Leeds |
Ian Rowe |
Fully Executed |
Yes |
Performed |
Yes |
06/06/2022 |
43 |
|
Nottingham |
Aloysious Aravinthan |
Fully Executed |
Yes |
Performed |
Yes |
07/07/2022 |
52 |
|
Wycombe |
James Maggs |
Fully Executed |
Yes |
Performed |
Yes |
11/07/2022 |
13 |
|
Basingstoke |
Kamran Ala |
Fully Executed |
Yes |
Performed |
Yes |
21/07/2022 |
7 |
|
Liverpool |
Tim Cross |
Fully Executed |
Yes |
Performed |
Yes |
22/07/2022 |
112 |
|
Portsmouth |
Richard Aspinall |
Fully Executed |
Yes |
Performed |
Yes |
28/07/2022 |
54 |
|
Co. Durham & Darlington |
Francisco Porras Perez |
Fully Executed |
Yes |
Performed |
Yes |
01/08/2022 |
20 |
|
Aintree |
Nick Stern |
Fully Executed |
Yes |
Performed |
Yes |
16/08/2022 |
100 |
|
Bristol - Weston |
PI Gau Appanna Sub-I Andrew Bell |
Fully Executed |
Yes |
Performed Performed |
Yes |
06/09/2022 15/11/2022 |
14 2 |
|
Bournemouth |
Safa Al-Shamma |
Fully Executed |
Yes |
Performed |
Yes |
12/09/2022 |
17 |
|
Royal Free |
Aileen Marshall |
Fully Executed |
Yes |
Performed |
Yes |
14/09/2022 |
9 |
|
Southampton |
Mark Wright |
Fully Executed |
Yes |
Performed |
Yes |
22/09/2022 |
31 |
|
Birmingham |
Tahir Shah |
Fully Executed |
Yes |
Performed |
Yes |
10/10/2022 |
7 |
|
East Kent |
Christopher Fox |
Fully Executed |
Yes |
Performed |
Yes |
13/10/2022 |
20 |
|
Cornwall |
Fiona Hammonds |
Fully Executed |
Yes |
Performed |
Yes |
07/12/2022 |
11 |
|
Guys and St Thomas' |
Bo Wang |
Fully Executed |
Yes |
Performed |
Yes |
12/12/2022 |
17 |
|
Royal Devon |
Christina Levick |
Fully Executed |
Yes |
Performed |
Yes |
17/01/2023 |
23 |
|
Derby - Burton |
Andrew Austin |
Fully Executed |
Yes |
Performed |
Yes |
03/02/2023 23/05/2023 |
13 1 |
|
Royal London |
Janet Dearden |
Fully Executed |
Yes |
Performed |
Yes |
20/02/2023 |
10 |
|
Manchester |
Martin Prince |
Fully Executed |
Yes |
Performed |
Yes |
01/03/2023 |
8 |
|
Gloucester |
Coral Hollywood |
Fully Executed |
Yes |
Performed |
Yes |
14/03/2023 |
12 |
|
Leicester |
Ka-Kit Li |
Fully Executed |
Yes |
Performed |
Yes |
21/03/2023 |
12 |
|
Newcastle |
Stuart McPherson |
Fully Executed |
Yes |
Performed |
Yes |
31/03/2023 |
77 |
|
NNUH |
Simon Rushbrook |
Fully Executed |
Yes |
Performed |
Yes |
19/04/2023 |
5 |
|
Milton Keynes |
Prakash Gupta |
Fully Executed |
Yes |
Performed |
Yes |
29/06/2023 |
3 |
|
Gateshead |
Dina Mansour |
Fully Executed |
Yes |
Performed |
Yes |
|
|
|
Total Patients Recruited |
|
|
|
|
|
|
1252 |
SELINA recruitment update
|
Site |
PI |
mNCA Status |
C&C Approved |
SIV |
Green Light Issued |
First Patient Recruited |
No. Patients Recruited |
|
Oxford |
Emma Culver |
Fully Executed |
Yes |
Performed |
Yes |
23/05/2022 |
18 |
|
Leeds |
Ian Rowe |
Fully Executed |
Yes |
Performed |
Yes |
27/07/2022 |
8 |
|
Plymouth |
Matthew Cramp |
Fully Executed |
Yes |
Performed |
Yes |
16/08/2022 |
5 |
|
Royal Free |
Aileen Marshall |
Fully Executed |
Yes |
Performed |
Yes |
03/10/2022 |
9 |
|
Birmingham |
Tahir Shah |
Fully Executed |
Yes |
Performed |
Yes |
16/11/2022 |
7 |
|
Nottingham |
Guru Aithal |
Fully Executed |
Yes |
Performed |
Yes |
30/11/2022 |
3 |
|
Liverpool |
Tim Cross |
Fully Executed |
Yes |
Performed |
Yes |
13/12/2022 |
8 |
|
Royal Devon |
Christina Levick |
Fully Executed |
Yes |
Performed |
Yes |
01/02/2023 |
3 |
|
Aintree |
Nick Stern |
Fully Executed |
Yes |
Performed |
Yes |
22/02/2023 |
4 |
|
Southampton |
Janisha Patel |
Fully Executed |
Yes |
Performed |
Yes |
16/03/2023 |
11 |
|
Newcastle |
Helen Reeves |
Fully Executed |
Yes |
Performed |
Yes |
15/05/2023 |
4 |
|
NNUH |
Simon Rushbrook |
Fully Executed |
Yes |
Performed |
Yes |
|
|
|
Bournemouth |
Jo Tod |
Fully Executed |
Yes |
Performed |
Yes |
|
|
|
Royal London |
Janet Dearden |
Fully Executed |
Yes |
Performed |
Yes |
|
|
|
Total Patients Recruited |
|
|
|
|
|
|
81 |
Kind Regards
Ellie, Jenni, Emily, Andy, James and Will