Dear study teams,
We’re delighted to have recruited the 1000th patient into the Pearl study in the last couple of weeks. This is a major milestone for the study and we remain so grateful for all the hard work you have put into recruitment so far.
Extra special thanks go to our recent sites of the month – be on the lookout for a token of our appreciation – these are St George’s, Liverpool and Newcastle
PEARL
We are in the process of making a protocol amendment to the Pearl study – the two key points that will affect recruiting sites are detailed below:
- Extension to recruitment end date – the current recruitment end date is 31st July 2023. This will be extended for another year (exact date TBC). Although some of you are approaching, or have surpassed your recruitment targets already, we’d like to encourage you to continue recruiting as many patients as you are able – we’ve still got a way to go to reach our overall target of 3000.
- Follow up visit window extended – currently, we are asking that follow up visits be performed annually from the date of recruitment. Due to the longer than originally planned recruitment period and budgetary constraints, we have decided to extend the follow up window to 18 months. This means that participants will now only have 3 scheduled study visits: Baseline -> 1st follow up (at baseline + 18 months) -> 2nd follow up (at 1st FU + 18 months). For those of you who have already begun performing follow up visits, we’d ask you to continue this as originally planned (every 12 months) until the amendment has been approved, we will of course send out further information when this takes place.
We are also seeing some of our Pearl patients being diagnosed with HCC. We know that this can be a sensitive time, but we’d like to emphasise the importance of performing a visit prior to any treatment for the HCC and collection of blood/urine samples and data. These form a really key part of the study and are incredibly valuable to us.
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 |
97 |
Hull |
Lynsey Corless |
Fully Executed |
Yes |
Performed |
Yes |
24/03/2022 |
46 |
Plymouth |
Matthew Cramp |
Fully Executed |
Yes |
Performed |
Yes |
13/04/2022 |
68 |
St George's |
Dan Forton |
Fully Executed |
Yes |
Performed |
Yes |
26/04/2022 |
48 |
Kings |
Kosh Agarwal |
Fully Executed |
Yes |
Performed |
Yes |
29/04/2022 |
70 |
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 |
8 |
Middlesbrough |
Darren Craig |
Fully Executed |
Yes |
Performed |
Yes |
26/05/2022 |
59 |
Imperial |
Nowlan Selvapatt |
Fully Executed |
Yes |
Performed |
Yes |
30/05/2022 |
29 |
Leeds |
Ian Rowe |
Fully Executed |
Yes |
Performed |
Yes |
06/06/2022 |
40 |
Nottingham |
Aloysious Aravinthan |
Fully Executed |
Yes |
Performed |
Yes |
07/07/2022 |
46 |
Wycombe |
James Maggs |
Fully Executed |
Yes |
Performed |
Yes |
11/07/2022 |
12 |
Basingstoke |
Kamran Ala |
Fully Executed |
Yes |
Performed |
Yes |
21/07/2022 |
4 |
Liverpool |
Tim Cross |
Fully Executed |
Yes |
Performed |
Yes |
22/07/2022 |
73 |
Portsmouth |
Richard Aspinall |
Fully Executed |
Yes |
Performed |
Yes |
28/07/2022 |
41 |
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 |
87 |
Bristol - Weston |
PI Gau Appanna Sub-I Andrew Bell |
Fully Executed |
Yes |
Performed Performed |
Yes |
06/09/2022 15/11/2022 |
14 |
Bournemouth |
Safa Al-Shamma |
Fully Executed |
Yes |
Performed |
Yes |
12/09/2022 |
15 |
Royal Free |
Aileen Marshall |
Fully Executed |
Yes |
Performed |
Yes |
14/09/2022 |
9 |
Southampton |
Mark Wright |
Fully Executed |
Yes |
Performed |
Yes |
22/09/2022 |
29 |
Birmingham |
Tahir Shah |
Fully Executed |
Yes |
Performed |
Yes |
10/10/2022 |
7 |
East Kent |
Christopher Fox |
Fully Executed |
Yes |
Performed |
Yes |
13/10/2022 |
18 |
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 |
9 |
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 |
9 1 |
Royal London |
Janet Dearden |
Fully Executed |
Yes |
Performed |
Yes |
20/02/2023 |
8 |
Manchester |
Martin Prince |
Fully Executed |
Yes |
Performed |
Yes |
01/03/2023 |
5 |
Gloucester |
Coral Hollywood |
Fully Executed |
Yes |
Performed |
Yes |
14/03/2023 |
7 |
Leicester |
Ka-Kit Li |
Fully Executed |
Yes |
Performed |
Yes |
21/03/2023 |
4 |
Newcastle |
Stuart McPherson |
Fully Executed |
Yes |
Performed |
Yes |
31/03/2023 |
43 |
NNUH |
Simon Rushbrook |
Fully Executed |
Yes |
Performed |
Yes |
19/04/2023 |
4 |
Sheffield |
Laura Harrison (Barbara Hoeroldt) |
With local R&D |
|
|
|
|
|
Milton Keynes |
Prakash Gupta |
Awaiting signature |
|
Performed |
|
|
|
Gateshead |
Dina Mansour |
Awaiting signature |
|
|
|
|
|
Total Patients Recruited |
|
|
|
|
|
|
1029 |
SELINA
Recruitment to the SELINA study seems to have slowed – new sites are welcome to join this study that is recruiting patients with small HCC - do please get in touch if we can help with this further, or if you feel that you can contribute to this study.
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 |
16 |
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 |
5 |
Birmingham |
Tahir Shah |
Fully Executed |
Yes |
Performed |
Yes |
16/11/2022 |
3 |
Nottingham |
Guru Aithal |
Fully Executed |
Yes |
Performed |
Yes |
30/11/2022 |
2 |
Liverpool |
Tim Cross |
Fully Executed |
Yes |
Performed |
Yes |
13/12/2022 |
5 |
Royal Devon |
Christina Levick |
Fully Executed |
Yes |
Performed |
Yes |
01/02/2023 |
3 |
Aintree |
Nick Stern |
Fully Executed |
Yes |
Performed |
Yes |
22/02/2023 |
2 |
Southampton |
Janisha Patel |
Fully Executed |
Yes |
Performed |
Yes |
16/03/2023 |
4 |
Newcastle |
Helen Reeves |
Fully Executed |
Yes |
Performed |
Yes |
15/05/2023 |
1 |
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 |
|
|
St George's |
Dan Forton |
With local R&D |
|
|
|
|
|
King’s |
|
With local R&D |
|
|
|
|
|
Total Patients Recruited |
|
|
|
|
|
|
54 |
Many, many thanks for all the hard work in recruiting and supporting the DeLIVER program.
Kind regards,
Ellie, Jenni, Emily, Will, James and Andy