Non-invasive Testing for Early oEesophageal Cancer and Dysplasia

Last updated: July 24, 2023
Sponsor: Imperial College London
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Cancer

Esophageal Disorders

Digestive System Neoplasms

Treatment

Breath test

Clinical Study ID

NCT04001478
19/LO/0780
  • Ages 18-90
  • Female

Study Summary

This study aims to determine whether a breath test could be used for early detection of oesophageal cancer and Barrett's high grade dysplasia.

Patients who are attending for a planned gastroscopy or who are scheduled to undergo elective resection of histologically confirmed early stage oesophageal adenocarcinoma or dysplasia will be approached to provide a breath sample.

Multi platform mass spectrometry analysis will be performed to establish volatile biomarkers that can discriminate between early stage (T1) oesophageal cancer/ Hight grade dysplasia from non cancer healthy controls/non dysplastic Barrett's cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18 years and ≤90 years of age
  • Undergoing gastroscopy or elective resection of histologically confirmed oesophagealadenocarcinoma/ high grade dysplasia
  • Fasted >6 hours
  • Able to provide informed written consent

Exclusion

Exclusion Criteria:

  • Any patient <18 years or >90 years of age.
  • Lacks capacity or is unable to provide informed written consent.

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Breath test
Phase:
Study Start date:
October 01, 2019
Estimated Completion Date:
October 31, 2024

Study Description

The incidence of oesophageal adenocarcinoma has been rising over the last decade. Despite improvements in oncological and surgical therapies the associated survival remains poor, mainly due to delays in diagnosis and advanced stage at presentation. Identifying patients at earlier stages as well as those at risk of cancer may lead to survival benefit. Barrett's oesophagus is an established risk factor for the development of oesophageal adenocarcinoma. It has an established histopathologic progression from low-grade, through high-grade dysplasia (HGD) to oesophageal adenocarcinoma (OAC). Barrett's oesophagus patients currently undergo regular endoscopic surveillance to allow earlier detection of oesophageal cancer.

The primary objective is to evaluate the diagnostic accuracy and clinical utility of the volatile organic compounds (VOC) in exhaled breath to detect early stage oesophageal adenocarcinoma and high-grade dysplastic Barrett's oesophagus.

All patients will be fasted for a minimum of 6 hours prior to the breath sample as part of their routine clinical care. Breath collection will be conducted using a previously validated method. Samples of breath (500ml) collected using "breath collecting device utilising bags". Breath samples collected within thermal desorption tubes (Markes International, Llantrisant, UK) will be transferred to a central laboratory for analysis by gas chromatography mass spectrometry (GC-MS) and proton transfer reaction time of flight mass spectrometry (PTR-ToF-MS). Raw data files will be extracted and analysed in accordance with established protocols.

Connect with a study center

  • University Hospitals Birmingham Nhs Foundation Trust

    Birmingham, B15 2TH
    United Kingdom

    Active - Recruiting

  • University Hospital Dorset NHS Foundation Trust

    Bournemouth, BH7 7DW
    United Kingdom

    Active - Recruiting

  • University Hospital Coventry and Warwickshire

    Coventry, CV2 2DX
    United Kingdom

    Active - Recruiting

  • Royal Liverpool University Hospital

    Liverpool, L7 8YE
    United Kingdom

    Active - Recruiting

  • Guy'S and St Thomas' Nhs Foundation Trust

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Imperial College Healthcare Trust

    London, W2 1NY
    United Kingdom

    Active - Recruiting

  • London North West University Healthcare Nhs Trust

    London, HA1 3UJ
    United Kingdom

    Site Not Available

  • University College London Hospitals Nhs Foundation Trust

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

  • Newcastle Hospital NHS Foundation Trust

    Newcastle Upon Tyne, NE4 5NR
    United Kingdom

    Active - Recruiting

  • Nottingham University Hospitals Nhs Trust

    Nottingham, NG7 2UH
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals Nhs Foundation Trust

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • Portsmouth Hospitals Nhs Trust

    Portsmouth, PO6 3LY
    United Kingdom

    Active - Recruiting

  • Salford Royal Nhs Foundation Trust

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

  • Betsi Cadwaladr University Health Board

    Wrexham, LL13 7YP
    United Kingdom

    Active - Recruiting

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