SPECTRA

• Research type

  Research Study

• Full title

  SPECTRA: Investigating Signal change in malignant and non-malignant Pleural Effusions and asCitic fluid using fTiR Analysis

• IRAS ID

  282414

• Contact name

  Anoop Chauhan

• Contact email

  anoop.chauhan@porthosp.nhs.uk

• Sponsor organisation

  Portsmouth Hospitals NHS Trust

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  This is an exploratory study to determine whether we can detect a difference in the FTIR signal between malignant and non-malignant (cancerous and non-cancerous) pleural effusions, and between malignant and non-malignant ascites.
  We aim to recruit a minimum of 120 participants. This study will take place at Queen Alexandra Hospital (QAH), Portsmouth, alongside standard medical care and will not require any additional procedures for the patient.
  Information will be collected about the results of standard biochemical, microbiological and cytological investigations plus the underlying diagnosis of the pleural effusion or ascites to determine whether signal changes can be detected.

  This study will have 3 phases:
  - Phase 1 will collect pleural fluid and ascitic fluid which will then be analysed on both an ATR-LVF and FTIR spectroscope by the PHT research laboratory team. The results will be shared with Glyconics (the company funding the study, who are working alongside another company called Spectrolytic), so we can determine what infrared range is required to analyse these samples. Phase 1 of this study also includes freezing samples and then thawing them to re-test them. This helps us to determine whether the freeze/thaw cycle will affect the results.
  - Phase 2 will collect further samples of pleural and ascitic fluid from patients undergoing these procedures as part of their standard medical care to test this specific infrared range. We will analyse the results following Phase 2 to help determine the number of participants we will need in phase 3.
  - Phase 3 will collect samples of fluid from a further group of participants. These will be used to confirm this specific infrared range accurately distinguishes between malignant and non-malignant pleural effusions and ascites.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  20/SC/0255

• Date of REC Opinion

  30 Jun 2020

• REC opinion

  Favourable Opinion