Early Diagnosis of Upper Digestive Tract Disease (E-DIGEST)

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Yan Mei Goh, MBChB, MRCS; Phone Number: 43396 0207 594 3396; Email: y.goh@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, W2 1NY
    • Recruiting
    • Imperial College London
    • Contact: Yan Mei Goh; Phone Number: 43396 0207 594 3396; Email: y.goh@imperial.ac.uk
    • Principal Investigator: George B Hanna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients recruited from secondary care will have been referred by their responsible clinician to undergo either a laryngoscopy (which involves visualisation of the highest part of the oesophagus, larynx and vocal cords, upper gastrointestinal endoscopy (which involves a telescope test to visualise the oesophagus, stomach and duodenum) or a lower gastrointestinal endoscopy (which involves a telescope test to visualise the colon) or surgery. No other investigations will be required.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Control
Oropharyngeal squamous cell carcinoma
Oesophageal squamous cell carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-invasive testing	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.	5 years

Collaborators and Investigators

• Sponsor: Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2019
• Primary Completion (Estimated): September 13, 2024
• Study Completion (Estimated): September 13, 2024

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: IRAS 257483

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No