Early Diagnosis of Upper Digestive Tract Disease

Recruiting

• Conditions: Diagnose Disease; Squamous Cell Carcinoma; Digestive System Disease; Breath Test

• Registration Number: NCT04475952
• Lead Sponsor: Imperial College London

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-13
• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-09-13
• Study Completion: 2025-09-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Any patient who:

  • is ≥ 18 years old and below 90 years of age, AND:
  • is undergoing endoscopy as part of their routine clinical care, OR:
  • is undergoing surgical resection of orodigestive tract disease as part of their routine clinical care, OR:
  • is undergoing treatment of orodigestive tract disease as part of their routine clinical care

Exclusion Criteria

• Any patient who:

  • Lacks capacity or is unable to provide informed consent.
  • Any patient below 18 years of age or over 90 years of age.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Non-invasive testing	5 years	Samples such as exhaled breath, urine, saliva, tissue and blood will be obtained from patients. These will be analysed with mass spectrometry to identify the compounds changed in patients with the target disease and those without.

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, United Kingdom