Non-invasive Testing for Early oEesophageal Cancer and Dysplasia

Barrett Esophagus Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04001478
• Other study ID #: 19/LO/0780
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: October 31, 2024

Study information

• Verified date: July 2023
• Source: Imperial College London
• Contact: Sara H Jamel, MBBS MRCS
• Phone: 02033126328
• Email: s.jamel[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Barrett Esophagus
• Barretts Esophagus With Dysplasia
• Esophageal Neoplasms
• Hyperplasia
• Oesophageal Cancer

Intervention

Diagnostic Test:
• Breath test
Patients will provide a breath test prior to gastroscopy or resection of Barrett's HGD lesion or oesophageal cancer.

Locations

Country	Name	City	State
United Kingdom	University Hospitals Birmingham Nhs Foundation Trust	Birmingham
United Kingdom	University Hospital Dorset NHS Foundation Trust	Bournemouth
United Kingdom	University Hospital Coventry and Warwickshire	Coventry
United Kingdom	Royal Liverpool University Hospital	Liverpool
United Kingdom	Guy'S and St Thomas' Nhs Foundation Trust	London
United Kingdom	Imperial College Healthcare Trust	London
United Kingdom	University College London Hospitals Nhs Foundation Trust	London
United Kingdom	Newcastle Hospital NHS Foundation Trust	Newcastle Upon Tyne
United Kingdom	Nottingham University Hospitals Nhs Trust	Nottingham
United Kingdom	Portsmouth Hospitals Nhs Trust	Portsmouth
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton
United Kingdom	Betsi Cadwaladr University Health Board	Wrexham

Sponsors (9)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3