RecruitingNCT04475952

Early Diagnosis of Upper Digestive Tract Disease


Sponsor

Imperial College London

Enrollment

180 participants

Start Date

Sep 13, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

Upper digestive tract cancer (UDC) is a major disease burden worldwide encompassing all cancers involving the digestive tract (from oral cavity to duodenum). A majority of patients presenting with this disease are diagnosed late and have poor overall survival rates (\<20%). NICE referral guidelines for diagnostic endoscopy are usually associated with late disease. Exhaled breath testing is a non-invasive and acceptable technology utilising mass spectrometry (MS) which has shown promise at diagnosing cancer at an early stage. Previous research has shown that products formed as a result of metabolism can be measured in breath and saliva (biomarkers). This has the ability to accurately identify patients with upper gastrointestinal (UGI) cancers from breath. Our initial pilot data has demonstrated that changes in the breakdown of metabolites release volatile organic compounds (VOC) which can be measured with MS. This data is supported by other patient studies. However no previous study has been performed utilising a non-invasive technique with breath and saliva. Thus the aim of this study is to identify VOCs present in patients with this disease. In this multi-centre study the investigators want to overcome the limitations of previous work by utilising non-invasive samples (breath, saliva and urine) in patients in multiple sites. The investigators aim to conduct a study in patients with UDC and those without. The investigators hope that the results of this study will provide evidence for large scale analysis of patients with this disease, demonstrate the feasibility of this technique and move this valuable test forward into mainstream medical practice. The major advantage of this test is that it is easy to undertake and painless for the patient. This study of products in breath, saliva and urine will be useful for detecting UDC to allow treatment at an early stage, improving overall survival.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is working to improve how doctors detect and diagnose diseases of the upper digestive tract — including the mouth, throat, esophagus, and stomach — at an early stage, when treatment is most effective. **You may be eligible if...** - You are between 18 and 90 years old - You are already scheduled for an endoscopy (a camera procedure to look inside your digestive tract) as part of your normal care - You are already scheduled for surgery or treatment for a disease of the upper digestive tract **You may NOT be eligible if...** - You are under 18 or over 90 years old - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Imperial College London

London, United Kingdom

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NCT04475952


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