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The 11th DeLIVER Newsletter

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

 

PEARL recruitment 11

 

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

 

 

 

 

 

 

SELINA recruitment 11

 

Kind Regards

Ellie, Jenni, Emily, Andy, James and Will