Actively Recruiting

Age: 18Years - 90Years
All Genders
Healthy Volunteers
NCT04475952

Early Diagnosis of Upper Digestive Tract Disease

Led by Imperial College London · Updated on 2025-02-10

180

Participants Needed

1

Research Sites

313 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Early Diagnosis of Upper Digestive Tract Disease

Who Can Participate

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older and younger than 90 years
  • Patients undergoing endoscopy as part of routine clinical care
  • Patients undergoing surgical resection of orodigestive tract disease as part of routine clinical care
  • Patients undergoing treatment of orodigestive tract disease as part of routine clinical care
Not Eligible

You will not qualify if you...

  • Patients unable to provide informed consent
  • Patients younger than 18 years or older than 90 years

AI-Screening

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Trial Site Locations

Total: 1 location

1

Imperial College London

London, United Kingdom, W2 1NY

Actively Recruiting

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Research Team

Y

Yan Mei Goh, MBChB, MRCS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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