Non-invasive Testing for Early oEesophageal Cancer and Dysplasia (NEED)
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| ClinicalTrials.gov Identifier: NCT04001478 |
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Recruitment Status :
Recruiting
First Posted : June 28, 2019
Last Update Posted : July 25, 2023
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Oesophageal Cancer Barrett Esophagus Barretts Esophagus With Dysplasia | Diagnostic Test: Breath test |
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 |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Non-invasive Testing for the Diagnosis of Early Oesophageal Cancer and Barrett's Dysplasia |
| Actual Study Start Date : | October 1, 2019 |
| Estimated Primary Completion Date : | October 31, 2024 |
| Estimated Study Completion Date : | October 31, 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Diagnostic Test: Breath test
Patients will provide a breath test prior to gastroscopy or resection of Barrett's HGD lesion or oesophageal cancer. |
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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.
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Diagnostic Test: Breath test
Patients will provide a breath test prior to gastroscopy or resection of Barrett's HGD lesion or oesophageal cancer. |
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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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Diagnostic Test: Breath test
Patients will provide a breath test prior to gastroscopy or resection of Barrett's HGD lesion or oesophageal cancer. |
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001478
| Contact: Sara H Jamel, MBBS MRCS | 02033126328 | s.jamel@imperial.ac.uk | |
| Contact: George B Hanna, FRCS PhD | 02033126328 | g.hanna@imperial.ac.uk |
| United Kingdom | |
| University Hospitals Birmingham Nhs Foundation Trust | Recruiting |
| Birmingham, United Kingdom, B15 2TH | |
| Contact: Sara Jamel, MBBS MRCS s.jamel@imperial.ac.uk | |
| University Hospital Dorset NHS Foundation Trust | Recruiting |
| Bournemouth, United Kingdom, BH7 7DW | |
| Contact: Katja Christodoulou, MBBS MRCP k.christodoulou@imperial.ac.uk | |
| University Hospital Coventry and Warwickshire | Recruiting |
| Coventry, United Kingdom, CV2 2DX | |
| Contact: Katja Christodoulou, MBBS MRCP k.christodoulou@imperial.ac.uk | |
| Royal Liverpool University Hospital | Recruiting |
| Liverpool, United Kingdom, L7 8YE | |
| Contact: Katja Christodoulou, MBBS MRCP k.christodoulou@imperial.ac.uk | |
| University College London Hospitals Nhs Foundation Trust | Recruiting |
| London, United Kingdom, NW1 2PG | |
| Contact: Sara Jamel, MBBS MRCS s.jamel@imperial.ac.uk | |
| Guy'S and St Thomas' Nhs Foundation Trust | Recruiting |
| London, United Kingdom, SE1 9RT | |
| Contact: Sara Jamel, MBBS MRCS s.jamel@imperial.ac.uk | |
| Imperial College Healthcare Trust | Recruiting |
| London, United Kingdom, W2 1NY | |
| Contact: Sara H Jamel, MBBS MRCS s.jamel@imperial.ac.uk | |
| Contact: George B Hanna, FRCS PhD g.hanna@imperial.ac.uk | |
| Principal Investigator: George B Hanna, FRCS PhD | |
| Newcastle Hospital NHS Foundation Trust | Recruiting |
| Newcastle Upon Tyne, United Kingdom, NE4 5NR | |
| Contact: Katja Christodoulou, MBBS MRCP k.christodoulou@imperial.ac.uk | |
| Nottingham University Hospitals Nhs Trust | Recruiting |
| Nottingham, United Kingdom, NG7 2UH | |
| Contact: Sara Jamel, MBBS MRCS s.jamel@imperial.ac.uk | |
| Portsmouth Hospitals Nhs Trust | Recruiting |
| Portsmouth, United Kingdom, PO6 3LY | |
| Contact: Sara Jamel, MBBS MRCS s.jamel@imperial.ac.uk | |
| University Hospital Southampton NHS Foundation Trust | Recruiting |
| Southampton, United Kingdom, SO16 6YD | |
| Contact: Katja Christodoulou, MBBS MRCP k.christodoulou@imperial.ac.uk | |
| Betsi Cadwaladr University Health Board | Recruiting |
| Wrexham, United Kingdom, LL13 7YP | |
| Contact: Katja Christodoulou, MBBS MRCP k.christodoulou@imperial.ac.uk | |
| Principal Investigator: | George B Hanna, FRCS PhD | Imperial College London |
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT04001478 |
| Other Study ID Numbers: |
19/LO/0780 |
| First Posted: | June 28, 2019 Key Record Dates |
| Last Update Posted: | July 25, 2023 |
| Last Verified: | July 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Oesophageal Cancer Barretts Esophagus with Dysplasia |
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Barrett Esophagus Esophageal Neoplasms Hyperplasia Pathologic Processes Precancerous Conditions Neoplasms Esophageal Diseases |
Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms |