Clinical trial NCT04001478: Non-invasive Testing for Early oEesophageal Cancer and Dysplasia
Official title: Non-invasive Testing for the Diagnosis of Early Oesophageal Cancer and Barrett's Dysplasia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oesophageal Cancer
Barrett Esophagus
Barretts Esophagus With Dysplasia
Keywords: Oesophageal Cancer
Barretts Esophagus with Dysplasia
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Guts UK
name: University College London Hospitals
name: Guy's and St Thomas' NHS Foundation Trust
name: Oxford University Hospitals NHS Trust
name: Nottingham University Hospitals NHS Trust
name: University Hospital Birmingham NHS Foundation Trust
name: Northern Care Alliance NHS Foundation Trust
name: London North West Healthcare NHS Trust
First posted: 2019-06-28
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the diagnostic accuracy of breath test for detection of early oesophageal cancer and Barrett's high grade dysplasia
timeFrame: 4 years
Secondary outcomes:
measure: Diagnostic validation study of the breath profile for prediction of early oeosphageal cancer and high grade dysplasia
timeFrame: 3
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham Nhs Foundation Trust
city: Bournemouth
country: United Kingdom
facility: University Hospital Dorset NHS Foundation Trust
city: Coventry
country: United Kingdom
facility: University Hospital Coventry and Warwickshire
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: University College London Hospitals Nhs Foundation Trust
city: London
country: United Kingdom
facility: Guy'S and St Thomas' Nhs Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle Hospital NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals Nhs Trust
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals Nhs Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
city: Wrexham
country: United Kingdom
facility: Betsi Cadwaladr University Health Board
Study officials:
affiliation: Imperial College London
name: George B Hanna, FRCS PhD
role: PRINCIPAL_INVESTIGATOR
References: