Early Diagnosis of Upper Digestive Tract Disease

  • STATUS
    Recruiting
  • participants needed
    180
  • sponsor
    Imperial College London
Updated on 19 February 2024
cancer
early diagnosis
cavity
endoscopy
breakdown
cavities
mass spectrometry
gastrointestinal disorder
early detection
volatile organic compounds
diagnostic endoscopy

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.

Details
Condition Breath Test, Carcinoma, vulvar dysplasia and carcinoma, Squamous cell carcinoma, Squamous cell carcinoma, Digestive System Disease, vulvar dysplasia and carcinoma, Diagnose Disease
Age 18-90 years
Clinical Study IdentifierNCT04475952
SponsorImperial College London
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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