BP40212 - ENDEAVOUR RWD - Lymphoma Study at The Christie Hospital
Research type
Research Database
IRAS ID
234834
Contact name
John Radford
Contact email
Research summary
BP40212 -The Christie Database - Step 1
REC name
West of Scotland REC 3
REC reference
18/WS/0039
Date of REC Opinion
29 Mar 2018
REC opinion
Favourable Opinion
Data collection arrangements
This study involves the collection and storage of retrospective data from patients who were diagnosed with relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) or relapsed/refractory Follicular Lymphoma (FL) and were treated at The Christie Hospital NHS Foundation Trust between 1st January 2006 and 31 December 2016.
Authorised employees from the Christie NHS Foundation Trust will be responsible for extracting eligible patient data from the existing Christie electronic health record (EHR) database known as CWP and occasionally from paper case notes. The data extracted will be entered manually into a bespoke electronic data capture form (EDC form) which will sit within the existing electronic health record (EHR) database. This will be accessed by a small number of Christie employees and fully anonymised before the secure data transmission to Roche occurs. The following patient data will be selected based on the following inclusion criteria:
•Age 18 years
•Histologically documented DLBCL or FL
•No history of transformation from indolent disease (relapsed/refractory DLBCL ONLY)
•Follicular lymphoma Grade 1-3a (relapsed/refractory FL ONLY)
•Treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody
•At least 1 year of follow-up time after the relapsed/refractory diagnosis or until.All data will be anonymised by The Christie research team before transferring to F-Hoffman La Roche for analysis.
Research programme
There is no specific research programme/community supported by this database as this is a pilot project.
Research database title
BP40212 -The Christie Database - Step 1
Establishment organisation
The Christie NHS Foundation Trust
Establishment organisation address
Wilmslow Road
Manchester
M20 4BX