TSB - STRATFix
Research type
Research Study
Full title
STRATFix: Enabling stratified medicine with novel fixatives for improved pre-analytical pathology workflows
IRAS ID
159051
Contact name
Jennifer Peach
Contact email
Duration of Study in the UK
4 years, 1 months, 28 days
Research summary
Current methods for preserving tissue samples for pathology tests are rapidly becoming the rate-limiting step in development and uptake of methods for molecular diagnosis of cancers and other diseases. Personalised ('stratified') medicine is a major goal of current healthcare policy in the UK and delivery of personalised treatment to patients increasingly requires molecular testing of tissue samples. Tissue preservatives ('fixatives') containing formaldehyde have been used for many years to allow high quality microscopic examination of tissue samples. However, these chemically alter molecules present in cells, including many that are useful markers of disease behaviour (e.g., how quickly a cancer will grow, whether it will metastasis and what drugs it respond to). Such markers are referred to as 'biomarkers' and include proteins and nucleic acids.
Development of new molecular testing methods like next generation sequencing (NGS) and quantitative polymerase chain reactions (qPCR) allows detection of a rapidly increasing range of biomarkers and cancer-associated mutations in tumour samples. These methods are needed to provide personalised diagnostic results for patients to ensure they receive ideal treatment. Fixation artefacts associated with using formaldehyde are currently limiting their application, particularly when only small diagnostic biopsy samples are available. To overcome these limitations, a consortium of pathologists at multiple sites throughout the UK, in collaboration with QIAGEN, will work together to perform a systematic study of new formalin-free fixation methods to preserve surgically removed tissue, needle core biopsy specimens and fine needle aspirate specimens. This partnership of hospital-based pathology laboratories and the established multinational company QIAGEN offers a unique opportunity to access a broad range of sample types and to align new tissue preservation methods with established workflows for pathology samples in diagnostic settings. This will give us a very strong evidence base from which to promote widespread uptake of new methods throughout the UK pathology community.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
15/YH/0221
Date of REC Opinion
1 May 2015
REC opinion
Favourable Opinion