Non-invasive Testing for Early oEesophageal Cancer and Dysplasia (NEED)

July 24, 2023 updated by: Imperial College London

Non-invasive Testing for the Diagnosis of Early Oesophageal Cancer and Barrett's Dysplasia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust
        • Contact:
      • Bournemouth, United Kingdom, BH7 7DW
      • Coventry, United Kingdom, CV2 2DX
      • Liverpool, United Kingdom, L7 8YE
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's and St Thomas' NHS Foundation Trust
        • Contact:
      • London, United Kingdom, W2 1NY
        • Recruiting
        • Imperial College Healthcare Trust
        • Contact:
        • Contact:
        • Principal Investigator:
          • George B Hanna, FRCS PhD
      • London, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospitals NHS Foundation Trust
        • Contact:
      • Newcastle Upon Tyne, United Kingdom, NE4 5NR
      • Nottingham, United Kingdom, NG7 2UH
        • Recruiting
        • Nottingham University Hospitals NHS Trust
        • Contact:
      • Portsmouth, United Kingdom, PO6 3LY
      • Southampton, United Kingdom, SO16 6YD
      • Wrexham, United Kingdom, LL13 7YP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • ≥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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: 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.
Diagnostic test: 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.
Diagnostic test: Breath test
Patients will provide a breath test prior to gastroscopy or resection of Barrett's HGD lesion or oesophageal cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the diagnostic accuracy of breath test for detection of early oesophageal cancer and Barrett's high grade dysplasia
Time Frame: 4 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic validation study of the breath profile for prediction of early oeosphageal cancer and high grade dysplasia
Time Frame: 3
After diagnostic accuracy has been determined as per objective 1 by the discovery phase of the proposed study, a validation phase will then follow to confirm findings. Diagnostic accuracy of the validation phase results will be measured by calculating the sensitivity and specificity of the test for detection of T1 oesophageal cancer and 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.
3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

University College London Hospitals
Northern Care Alliance NHS Foundation Trust
Nottingham University Hospitals NHS Trust
Guy's and St Thomas' NHS Foundation Trust
University Hospital Birmingham NHS Foundation Trust
Oxford University Hospitals NHS Trust
London North West Healthcare NHS Trust
Guts UK

Investigators

  • Principal Investigator: George B Hanna, FRCS PhD, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (Actual)

June 28, 2019

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19/LO/0780

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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