Ex-MORE version 1.0
Research type
Research Study
Full title
Use of existing samples from cancer patients consented to a previous study for Pre-Clinical Models and Drug Development
IRAS ID
322828
Contact name
GJ Miles
Contact email
Sponsor organisation
University of Leicester, Research & Enterprise Division
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
Despite a plethora of pre-clinical models available for drug development, there is a lack of models that can accurately predict patient outcomes and that are indeed patient relevant. The Leicester Cancer Research Centre runs a Patient-Derived Explant (PDE) Facility, which collects fresh patient cancer tissues and uses these to test the effect of current chemotherapies and novel drugs in patient tissues. The tissues are then evaluated for markers of tumour cell death to determine how efficacious the therapies have been. These samples are then assessed for novel biomarkers for each drug to determine how effective each drug might be in the clinic for specific cancer patients.
We have previously consented up to 242 patients to a prior study (ExPAT, Ethics Ref: 14/WA/1166) and processed patient specimens into formalin fixed paraffin embedded (FFPE) tissue, collected patient blood for DNA analysis and relative histo-pathology data. The ExPAT Ethics has now expired, but we wish to obtain ethical approval to transfer the samples to a new project.
The new study involves the storage, maintenance and use of blood samples and FFPE blocks from human tumour specimens and relative histo-pathology data collected from previously consented cancer patients. Using protein and DNA based methodologies we aim to assess cancer tissue responses to drug treatments and changes in key cancer associated normal cells such as immune cells.
REC name
London - Stanmore Research Ethics Committee
REC reference
23/PR/0805
Date of REC Opinion
8 Aug 2023
REC opinion
Favourable Opinion