Oesophageal CancerNEEDNCT04001478
Non-invasive Testing for Early oEesophageal Cancer and Dysplasia
An observational study of Oesophageal Cancer and Barrett Esophagus, run by Imperial College London at 12 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Oesophageal Cancer, Barrett Esophagus, Barretts Esophagus With Dysplasia
- What is being tested?
- Breath test
- How many people
- 1,000 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- 1 Oct 2019to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- ≥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
Who cannot join
- Any patient <18 years or >90 years of age.
- Lacks capacity or is unable to provide informed written consent.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United Kingdom12 sites, 12 recruiting
- Recruiting
University Hospitals Birmingham Nhs Foundation Trust
Birmingham, B15 2TH
Sara Jamel, MBBS MRCS, s.jamel@imperial.ac.uk
- Recruiting
University Hospital Dorset NHS Foundation Trust
Bournemouth, BH7 7DW
Katja Christodoulou, MBBS MRCP, k.christodoulou@imperial.ac.uk
- Recruiting
University Hospital Coventry and Warwickshire
Coventry, CV2 2DX
Katja Christodoulou, MBBS MRCP, k.christodoulou@imperial.ac.uk
- Recruiting
Royal Liverpool University Hospital
Liverpool, L7 8YE
Katja Christodoulou, MBBS MRCP, k.christodoulou@imperial.ac.uk
- Recruiting
University College London Hospitals Nhs Foundation Trust
London, NW1 2PG
Sara Jamel, MBBS MRCS, s.jamel@imperial.ac.uk
- Recruiting
Guy'S and St Thomas' Nhs Foundation Trust
London, SE1 9RT
Sara Jamel, MBBS MRCS, s.jamel@imperial.ac.uk
- Recruiting
Imperial College Healthcare Trust
London, W2 1NY
Sara H Jamel, MBBS MRCS, s.jamel@imperial.ac.uk
George B Hanna, FRCS PhD, g.hanna@imperial.ac.uk
- Recruiting
Newcastle Hospital NHS Foundation Trust
Newcastle upon Tyne, NE4 5NR
Katja Christodoulou, MBBS MRCP, k.christodoulou@imperial.ac.uk
- Recruiting
Nottingham University Hospitals Nhs Trust
Nottingham, NG7 2UH
Sara Jamel, MBBS MRCS, s.jamel@imperial.ac.uk
- Recruiting
Portsmouth Hospitals Nhs Trust
Portsmouth, PO6 3LY
Sara Jamel, MBBS MRCS, s.jamel@imperial.ac.uk
- Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
Katja Christodoulou, MBBS MRCP, k.christodoulou@imperial.ac.uk
- Recruiting
Betsi Cadwaladr University Health Board
Wrexham, LL13 7YP
Katja Christodoulou, MBBS MRCP, k.christodoulou@imperial.ac.uk
About this study
Official title: 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.
Read the 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.
- Being tested
- Breath test
- Keywords
- Oesophageal Cancer, Barretts Esophagus with Dysplasia
- Medical subject headings
- Esophageal Neoplasms, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath testDiagnostic test
Patients will provide a breath test prior to gastroscopy or resection of Barrett's HGD lesion or oesophageal cancer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Breath test | |
| 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. Receives: Diagnostic Test: Breath test | |
| 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. Receives: Diagnostic Test: Breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (1)
Diagnostic validation study of the breath profile for prediction of early oeosphageal cancer and high grade dysplasia
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.
Measured: 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start1 Oct 2019
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guts UK, University College London Hospitals, Guy's and St Thomas' NHS Foundation Trust, Oxford University Hospitals NHS Trust, Nottingham University Hospitals NHS Trust, University Hospital Birmingham NHS Foundation Trust, Northern Care Alliance NHS Foundation Trust, London North West Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- George B Hanna, FRCS PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001478
- Sponsor's protocol ID
- 19/LO/0780
- Acronym
- NEED
- Status last verified
- Jul 2023
- First submitted
- 26 Jun 2019
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Testing for the Diagnosis of Early Oesophageal Cancer and Barrett's Dysplasia
- ClinicalTrials.gov ID
- NCT04001478
- Acronym / sponsor ID
- NEED / 19/LO/0780
- Keywords
- Oesophageal Cancer, Barretts Esophagus with Dysplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Guts UK, University College London Hospitals, Guy's and St Thomas' NHS Foundation Trust, Oxford University Hospitals NHS Trust, Nottingham University Hospitals NHS Trust, University Hospital Birmingham NHS Foundation Trust, Northern Care Alliance NHS Foundation Trust, London North West Healthcare NHS Trust
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: Breath testPatients 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 | – | Diagnostic Test: Breath testPatients 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) | – | Diagnostic Test: Breath testPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (2 listed)
- Any patient <18 years or >90 years of age.
- Lacks capacity or is unable to provide informed written consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath testPatients will provide a breath test prior to gastroscopy or resection of Barrett's HGD lesion or oesophageal cancer. | Diagnostic test | Advanced Oesophageal cancer (T2/3/4), Control group, Early oesophageal cancer (T1)/ Barrett's high grade dysplasia |
Primary outcome
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.
1 secondary outcome
Diagnostic validation study of the breath profile for prediction of early oeosphageal cancer and high grade dysplasia
Time frame: 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George B Hanna, FRCS PhD principal investigator
Imperial College London
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oesophageal Cancer and Barrett Esophagus, run by Imperial College London at 12 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara H Jamel, MBBS MRCS (02033126328, s.jamel@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the diagnostic accuracy of breath test for detection of early oesophageal cancer and Barrett's high grade dysplasia (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.