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Welcome to the SHIELD Project

A Phase II Study (VEPEMB) in patients

with Hodgkin's lymphoma aged > 60 years

NEWCASTLE HODGKIN'S INDEX
On download, please double click Index.exe to start the index application and then click Run

Not signed up? Click here to begin to register your site

and participate in SHIELD
  SHIELD News  

CLICK ON THE TYNE BRIDGE TO THE RIGHT TO USE THE NEWCASTLE HODGKIN'S DISEASE INDEX

THE SHIELD STUDY IS NOW CLOSED TO RECRUITMENT.

Please do not add any further patients to this study, but do please continue to add follow-up data. The eCRF for each patient should be updated as necessary, in the SHIELD database, and QoL forms sent to the Newcastle Study Centre as usual.

Many thanks for your assistance.

PLEASE REMEMBER :  WE AIM TO REGISTER ALL HODGKIN'S LYMPHOMA PATIENTS OVER 60 YEARS, REGARDLESS OF TREATMENT, SUBJECT TO CONSENT

AUGUST 2009 - We now have  53 sites with SSIF and R&D approval.

THREE sites still awaiting R&D approval.

The SHIELD study will close to recruitment on 31 August 2009, and it is vital that all study data are archived promptly, fully and accurately. A Standard Operating Procedure (SOP) for Archiving is available in the Document Centre (see below). If you are required to use your own Trust SOP, then you should do so, but you must follow an archiving SOP.

If you have any queries regarding the study or archiving your data, please do not hesitate to contact either Jennifer Wilkinson or Gillian Watson at the Newcastle Study Centre.

We are relying on you to provide post-recruitment period data to make our study as comprehensive as possible. Many thanks for your assistance so far, and keep up the good work!”

THREE  sites still awaiting R&D approval.

232  PATIENTS RECRUITED

 

129  Registration   patients

103   VEPEMB study regimen patients

 

Please scroll down this page to the DOCUMENTS CENTRE to find:
June 2009 Newsletter
SHIELD Archiving SOP - August 2009

 

IMPORTANT NOTICES FOR INVESTIGATORS

The MHRA have issued the Study with a new CTA number.   Please scoll down to the relevant document in the DOCUMENTS CENTRE below.

SEPTEMBER, 2007: We have a new Protocol (Version 5 : 13.8.07) which accomodates a change to the GP letter.  This has been sent out in hard copy to all Principal Investigators. Scoll down this HOMEPAGE to the DOCUMENTS CENTRE to access this document and approval letters.  

 

February 2007 - MREC authorisation granted for extension of study end date to:   31st August 2009.

 

How to participate in SHIELD.

Any centre in Europe that treats Hodgkin's disease is eligible to participate - simply follow the link at the top right of this page to register as an investigator. You must be acting as Principle Investigator at your site to go through the registration process. Once registered (and validated by the Study Manager) you can add additional users at your site and begin to enter patients on the system. In the case of UK users, R&D and Local Ethical Approval are required before registering patients.

If you are a patient and are interested in the project, please speak to your own doctor who can advise you on whether participation is appropriate for you.

The SHIELD Project has been adopted by the UK National Cancer Research Network.

 

SCROLL DOWN THIS PAGE TO SEE THE DOCUMENTS YOU REQUIRE

FOR ETHICS AND R&D APPLICATIONS


Regular updates will be posted by the SHIELD Study Manager.

What is SHIELD and how do I get involved?

Hodgkin's lymphoma (or Hodgkin's Disease) is a curable cancer but outcome worldwide in the over 60 years age group has not improved over the last decade. The SHIELD Project asks 'why?' and aims to do something about it.

SHIELD aims to do two things:

1. Simply register elderly (>60) patients with Hodgkin's disease and collect simple data to understand the range of current therapies and outcomes whether or not the patient is on the VEPEMB study protocol.   Please ensure that you consent the patient, even if the Study Protocol is not to be used. What treatment you actually decide to give to the patient is equally important to this study.

2. Offer a phase II single arm interventional study using VEPEMB chemotherapy collecting more comprehensive data.

Investigators can choose either of the above - the use of VEPEMB is optional.

The wider objectives of SHIELD are:

- to implement uniform assessment, diagnosis and treatment of Hodgkin's lymphoma in patients older than 60 years, with a view to enhancing survival and quality of life. 

- to assess the objective response rate, event free and overall survival following treatment with a multi-agent standard cancer schedule in a new combination; Vinblastine, (Endoxana), Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone and Bleomycin (VEPEMB)

- to assess the nature and characteristics of patients with Hodgkin's lymphoma not able to participate in the VEPEMB study and provide models for alternative palliative treatments

- to use prognostic parameters (clinical and laboratory) to assess outcome prediction

The Chief Investigator is Professor Stephen J Proctor at the University of Newcastle.

The Study Manager is Mrs Jennifer Wilkinson

The Assistant Clinical Trial Manager assigned to the study is Ms Gillian Watson

You can download all the documents you need for the study from the document download centre below or if you wish, please call the trial office on +44 191 222 7791/7632 or email the trial staff using the above links if you need further information.
About the VEPEMB study element of the SHIELD Project

The VEPEMB study is a phase II study of Vinblastine, (Endoxana), Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone and Bleomycin in patients with Hodgkin's lymphoma, aged greater than 60 years. It is a UK National Cancer Research Network study.

The endpoints of the VEPEMB element of the SHIELD project are to assess the objective response rate, event free and overall survival following treatment with a multi-agent standard cancer schedule in a new combination; Vinblastine, (Endoxana), Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone and Bleomycin (VEPEMB).
SHIELD Document Centre
There are a number of documents that you will need to set up SHIELD at your site. These include supporting documents for Ethical Committee applications and information documents about the study. These can be downloaded using the links below.

Documents relating to Application for ethical approval

PDF files require 'Acrobat' software from Adobe. If you do not have this software, click here to download - it's free.

Document Notes Word
file		 PDF
file

MREC/MHRA approval letters - Protocol Version 5:

13.8.07

 Print copy for study file
-
PROTOCOL Version 5: 13.8.07 Print copy for study file download

Substantial Amendment Form :  Protocol Version 5

13.8.07

Print copy for study file download  
Approval documentation - extension study date to end of August 2009 Print copy for study file   download
VEPEMB Patient Information Sheet and Consent Form :  Version 5 dated 20.3.07 Modify information sheet (Word Doc) with local contact details. download
-
Registration Only :  Patient Information Sheet and Consent Form :   Version 1 dated 20.3.07 Modify information sheet (Word Doc) with local contact details.

-
Full MREC original application document  
-

download
Letter to GP re VEPEMB Study Patient Print copy for study file and add details for GP
Letter to GP re Registration Only Study Patient Print copy for study file and add details for GP download  
Site Specific Approval

SSI form can be obtained via the COREC Website

Please register with COREC then email jennifer.wilkinson@ncl.ac.uk. See latest IRAS guidelines.

 

Please note that a copy of the Local Investigator's CV must also be sent to the Local Ethics Committee.

Other Study Documents

Document Notes Word
file		 PDF
file
SOP SHIELD Trial Masterfile Use this SOP unless your Trust requires you to use their own SOP  
SHIELD Screening Log Record all patients screened for Study  
SHIELD Enrolment log Record all patients enrolled on Study  
SHIELD Signature & Delegation log To be completed for all Study Personnel  
eCrf Handbook - version 6 Handbook containing notes for completion of eCRF  
Latest Newsletter June 2009
Letter from Chief Investigator General introduction to SHIELD
MHRA letter re change of CTA number For investigator information only   download
MHRA CTA certificate For investigator information only
-
Sponsor/Site Clinical Trial Agreement - generic Contact jennifer.wilkinson@ncl.ac.uk to obtain copy specific for your site.
-
  
Quality of Life Questionnaire

To be completed by patient before treatment, after treatment, at 2 year follow-up and at 5 year follow-up.

Forward to Jennifer Wilkinson, Study Manager
 
Serious Adverse Event form To be faxed to the Chief Investigator, Professor S J Proctor at 0191 222 5524
Serious Adverse Event Follow Up form To be faxed to the Study Manager when outcome is unknown at time of sending original SAE
SOP for reporting SAEs Standard Operating Procedure for Reporting SAEs  
SOP for Archiving Standard Operating Procedure for Reporting SAEs  
       
       




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