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Spots Global Cancer Trial Database for Non-invasive Testing for Early oEesophageal Cancer and Dysplasia

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Trial Identification

Brief Title: 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 ID: NCT04001478

Interventions

Breath test

Study Description

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

University College London Hospitals Nhs Foundation Trust, London, , United Kingdom

Guy'S and St Thomas' Nhs Foundation Trust, London, , United Kingdom

Imperial College Healthcare 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, , United Kingdom

Contact Details

Name: George B Hanna, FRCS PhD

Affiliation: Imperial College London

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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