Non-invasive Testing for Early oEesophageal Cancer and Dysplasia
NEED
Non-invasive Testing for the Diagnosis of Early Oesophageal Cancer and Barrett's Dysplasia
1 other identifier
observational
1,000
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2019
CompletedFirst Posted
Study publicly available on registry
June 28, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedJuly 25, 2023
July 1, 2023
5.1 years
June 26, 2019
July 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the diagnostic accuracy of breath test for detection of early oesophageal cancer and Barrett's high grade dysplasia
Diagnostic accuracy will be measured by calculating the sensitivity and specificity of the test for detection of early oesophageal cancer/ high grade dysplasia. Sensitivity and specificity values are represented by a number between 0 to 1 indicating the test's ability to pick up true positive results and true negative results respectively, where a number closer to one indicates a greater detection ability.
4 years
Secondary Outcomes (1)
Diagnostic validation study of the breath profile for prediction of early oeosphageal cancer and high grade dysplasia
3
Study Arms (3)
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.
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.
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.
Interventions
Patients will provide a breath test prior to gastroscopy or resection of Barrett's HGD lesion or oesophageal cancer.
Eligibility Criteria
Patients attending for a planned gastroscopy as part of their Barrett's surveillance or under the two week wait rule or who are scheduled to undergo elective surgical or endoscopic resection of histologically confirmed early oesophageal adenocarcinoma/ high grade dysplasia will be eligible for inclusion in this study
You may qualify if:
- ≥18 years and ≤90 years of age
- Undergoing gastroscopy or elective resection of histologically confirmed oesophageal adenocarcinoma/ high grade dysplasia
- Fasted \>6 hours
- Able to provide informed written consent
You may not qualify if:
- Any patient \<18 years or \>90 years of age.
- Lacks capacity or is unable to provide informed written consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- Guts UKcollaborator
- University College London Hospitalscollaborator
- Guy's and St Thomas' NHS Foundation Trustcollaborator
- Oxford University Hospitals NHS Trustcollaborator
- Nottingham University Hospitals NHS Trustcollaborator
- University Hospital Birmingham NHS Foundation Trustcollaborator
- Northern Care Alliance NHS Foundation Trustcollaborator
- London North West Healthcare NHS Trustcollaborator
Study Sites (12)
University Hospitals Birmingham Nhs Foundation Trust
Birmingham, B15 2TH, United Kingdom
University Hospital Dorset NHS Foundation Trust
Bournemouth, BH7 7DW, United Kingdom
University Hospital Coventry and Warwickshire
Coventry, CV2 2DX, United Kingdom
Royal Liverpool University Hospital
Liverpool, L7 8YE, United Kingdom
University College London Hospitals Nhs Foundation Trust
London, NW1 2PG, United Kingdom
Guy'S and St Thomas' Nhs Foundation Trust
London, SE1 9RT, United Kingdom
Imperial College Healthcare Trust
London, W2 1NY, United Kingdom
Newcastle Hospital NHS Foundation Trust
Newcastle upon Tyne, NE4 5NR, United Kingdom
Nottingham University Hospitals Nhs Trust
Nottingham, NG7 2UH, United Kingdom
Portsmouth Hospitals Nhs Trust
Portsmouth, PO6 3LY, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD, United Kingdom
Betsi Cadwaladr University Health Board
Wrexham, LL13 7YP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George B Hanna, FRCS PhD
Imperial College London
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2019
First Posted
June 28, 2019
Study Start
October 1, 2019
Primary Completion
October 31, 2024
Study Completion
October 31, 2024
Last Updated
July 25, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share