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

  jennifer.peach@uhs.nhs.uk

• 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.

  Lay Summary of Results:

  The study compared a new tissue fixative PAXgene (PFPE) to the current gold standard of formalin (FFPE). The new fixative provides better presetvation of DNA for genetic testing. This study was to assess the tissue appearances and if they are suitable for diagnosis. PFPE samples showed increased fragility, particularly in necrotic areas where tearing of sections was more commonly seen. Average scores for PFPE (10.7 for pathologist 1 and 9.6 for pathologist 2) were slightly lower than those for FFPE tissue (11.8 for both pathologists). Lymph nodes showed noticeably inferior preservation in PAXgeneTissue, with cell shrinkage and tissue disaggregation as well as slightly less crisp nuclear features. Overall both pathologists assessed all FFPE as suitable for diagnosis and 89% of PFPE sections (16/18) as suitable for diagnosis.
  Has the registry been updated to include summary results?: No
  If yes - please enter the URL to summary results:
  If no – why not?: No suitable registry
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: Results were published and presented in conferences as posters
  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: No
  If yes, describe and/or provide URLs to materials shared and how they were shared:
  If pending, date when feedback is expected:
  If no, explain why they haven't: The samples were anonymised.
  Have you enabled sharing of study data with others?: No
  If yes, describe or provide URLs to how it has been shared:
  If no, explain why sharing hasn't been enabled: No suitable registry.
  Have you enabled sharing of tissue samples and associated data with others?: Yes
  If yes, describe or provide a URL:
  If no, explain why:
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• 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