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| Name | Class |
|---|---|
| Guts UK | OTHER |
| University College London Hospitals | OTHER |
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
| Oxford University Hospitals NHS Trust |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath test | Diagnostic Test | Patients will provide a breath test prior to gastroscopy or resection of Barrett's HGD lesion or oesophageal cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara H Jamel, MBBS MRCS | Contact | 02033126328 | s.jamel@imperial.ac.uk | |
| George B Hanna, FRCS PhD | Contact | 02033126328 | g.hanna@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| George B Hanna, FRCS PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Birmingham Nhs Foundation Trust | Recruiting | Birmingham | B15 2TH | United Kingdom |
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| 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 |
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| 3 |
| University Hospital Dorset NHS Foundation Trust | Recruiting | Bournemouth | BH7 7DW | United Kingdom |
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| University Hospital Coventry and Warwickshire | Recruiting | Coventry | CV2 2DX | United Kingdom |
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| Royal Liverpool University Hospital | Recruiting | Liverpool | L7 8YE | United Kingdom |
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| University College London Hospitals Nhs Foundation Trust | Recruiting | London | NW1 2PG | United Kingdom |
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| Guy'S and St Thomas' Nhs Foundation Trust | Recruiting | London | SE1 9RT | United Kingdom |
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| Imperial College Healthcare Trust | Recruiting | London | W2 1NY | United Kingdom |
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| Newcastle Hospital NHS Foundation Trust | Recruiting | Newcastle upon Tyne | NE4 5NR | United Kingdom |
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| Nottingham University Hospitals Nhs Trust | Recruiting | Nottingham | NG7 2UH | United Kingdom |
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| Portsmouth Hospitals Nhs Trust | Recruiting | Portsmouth | PO6 3LY | United Kingdom |
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| University Hospital Southampton NHS Foundation Trust | Recruiting | Southampton | SO16 6YD | United Kingdom |
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| Betsi Cadwaladr University Health Board | Recruiting | Wrexham | LL13 7YP | United Kingdom |
|
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D011230 | Precancerous Conditions |
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| ID | Term |
|---|---|
| D001944 | Breath Tests |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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