GItractRS_SMART_RetroArchive

  • Research type

    Research Study

  • Full title

    Evaluation of the role of Raman spectroscopy in the diagnosis and management of premalignant and malignant disease of the gastrointestinal tract [SMART: Stratified Medicine through Advanced Raman Technologies] Retrospective access to archived tissue

  • IRAS ID

    180047

  • Contact name

    Catherine Kendall

  • Contact email

    catherine.kendall1@nhs.net

  • Sponsor organisation

    Gloucestershire Hospital NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    n/a, n/a

  • Duration of Study in the UK

    21 years, 6 months, 26 days

  • Research summary

    Cancer affects one in three people in the UK. Histopathology, the current gold standard for cancer diagnosis, is still mainly a subjective technique. This leads to significant issues when identifying patients in early stage disease who could be treated more conservatively. Agreement between pathologists for early neoplasias can be below 50%. Further, more accurate objective methods of identifying those patients who will progress rapidly to advanced diseases are vital.

    Raman spectroscopy (RS) is a non-invasive analytic tool that uses the laser light to identify the molecular composition of different tissues or materials. A significant body of research has been conducted exploring the potential of Raman spectroscopy as adjunct to aid to histopathological diagnosis of cancer. Raman provides disease-specific molecular signals from unlabelled tissues in a reproducible manner. This opens up the possibility of clinical decision-making at early neoplastic stages of disease.

    This study will evaluate the performance of a novel Fast Raman imaging system. This offers significant benefits to stratified medicine through improved and earlier detection, increased specificity - improved morbidity, mortality rates, savings from more targeted treatment, savings from faster diagnosis and reduced repeat surgery (in-vivo in theatre analysis).

    Archived pathology specimens will be used in this study. Sections will be cut for spectroscopy and routine histopathology review to compare the accuracy of the spectral classification model against accepted gold standard.

    In order to evaluate system transferability between hospitals or research laboratories, spectral measurements will carried out at Gloucestershire Hospitals NHS Foundation Trust and sections will be distributed to University of Exeter and University College London. Each of these sites has comparable Raman spectroscopic system.

  • REC name

    London - Fulham Research Ethics Committee

  • REC reference

    15/LO/1314

  • Date of REC Opinion

    27 Jul 2015

  • REC opinion

    Further Information Favourable Opinion