Pre_HOLD version 1.0
Research type
Research Study
Full title
Use of existing FFPE blocks of human tissue specimens from patients pre-2006 and part of the University of Leicester Cancer Research Centre sample holdings.
IRAS ID
343618
Contact name
GJ Miles
Contact email
Sponsor organisation
University of Leicester, Research & Enterprise Division
Duration of Study in the UK
10 years, 0 months, 0 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 (LCRC) 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.
When evaluating novel anti-cancer agents, it is critically important to evaluate target expression in different cancers (disease positioning), alongside potential novel predictive and pharmacodynamic biomarkers of response to improve rationale designed stratified clinical trial design. Additionally, it is important to also assess target expression in “normal” tissues to investigate potential “on-target” toxicity. The LCRC has pre-existing holdings of human tissue specimens (normal and cancerous) in formalin-fixed, paraffin-embedded (FFPE) blocks collected before 2006.
This archive of human tissues will be used to investigate novel biomarkers and anti-cancer drug targets. We wish to obtain ethical approval for the storage, maintenance and use of these samples in future studies using a range of molecular modalities (e.g. IHC, FISH, Proteomics, RNAseq, NGS etc) to undertake quantitative analysis of biomarkers expression in healthy tissues compared to tumour tissues.
REC name
North of Scotland Research Ethics Committee 2
REC reference
24/NS/0078
Date of REC Opinion
26 Jul 2024
REC opinion
Further Information Favourable Opinion