Non-invasive Testing for Early oEesophageal Cancer and Dysplasia
NCT ID: NCT04001478
Last Updated: 2023-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2019-10-01
2024-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Control group
Patients who are attending hospital for a gastroscopy as part of their routine clinical care as a 2 week wait rule referral and those on Barrett's surveillance , will be asked to give a sample of their breath prior to the procedure.
Breath test
Patients will provide a breath test prior to gastroscopy or resection of Barrett's HGD lesion or oesophageal cancer.
Early oesophageal cancer (T1)/ Barrett's high grade dysplasia
Patients who have known pre-diagnosed T1 oesophageal adenocarcinoma or HGD attending hospital as part of their clinical care will be asked to give a breath sample prior to their endoscopy resection/ cancer operation. Patients will be sampled upon return for follow up endoscopy to assess breath profile changes and correlation with endoscopy findings.
Breath test
Patients will provide a breath test prior to gastroscopy or resection of Barrett's HGD lesion or oesophageal cancer.
Advanced Oesophageal cancer (T2/3/4)
Patients who have been diagnosed with oesophageal adenocarcinoma attending hospital as part of their clinical care will be asked to give a breath sample prior to their endoscopy resection/ cancer operation.
Breath test
Patients will provide a breath test prior to gastroscopy or resection of Barrett's HGD lesion or oesophageal cancer.
Interventions
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Breath test
Patients will provide a breath test prior to gastroscopy or resection of Barrett's HGD lesion or oesophageal cancer.
Eligibility Criteria
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Inclusion Criteria
* Undergoing gastroscopy or elective resection of histologically confirmed oesophageal adenocarcinoma/ high grade dysplasia
* Fasted \>6 hours
* Able to provide informed written consent
Exclusion Criteria
* Lacks capacity or is unable to provide informed written consent.
18 Years
90 Years
FEMALE
No
Sponsors
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Guts UK
OTHER
University College London Hospitals
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
Oxford University Hospitals NHS Trust
OTHER
Nottingham University Hospitals NHS Trust
OTHER
University Hospital Birmingham NHS Foundation Trust
OTHER
Northern Care Alliance NHS Foundation Trust
OTHER
London North West Healthcare NHS Trust
OTHER
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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George B Hanna, FRCS PhD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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University Hospitals Birmingham Nhs Foundation Trust
Birmingham, , United Kingdom
University Hospital Dorset NHS Foundation Trust
Bournemouth, , United Kingdom
University Hospital Coventry and Warwickshire
Coventry, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
University College London Hospitals Nhs Foundation Trust
London, , United Kingdom
Guy'S and St Thomas' Nhs Foundation Trust
London, , United Kingdom
Imperial College Healthcare Trust
London, , United Kingdom
Newcastle Hospital NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Nottingham University Hospitals Nhs Trust
Nottingham, , United Kingdom
Portsmouth Hospitals Nhs Trust
Portsmouth, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Betsi Cadwaladr University Health Board
Wrexham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19/LO/0780
Identifier Type: -
Identifier Source: org_study_id
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