eDIGEST

Early diagnosis of upper DIGESTive tract disease

Completed
Cancer Focus
Upper Digestive Tract (OAC, OSCC, HNSCC)
Sponsor
Imperial College London
Funding
Medical Research Council (MRC)
ClinicalTrials.gov
CPMS ID
42784

Background

Upper digestive tract cancers encompass all cancers from the oral cavity to the duodenum. Patients present with indeterminate symptoms, so definitive presentation tends to occur late, with a five-year survival rate of 8.3–19%. With increasing incidence worldwide, there is a need for a non-invasive diagnostic tool for earlier identification. Analysis of VOCs from breath, saliva and urine can provide a non-invasive risk-stratification tool to identify high-risk patients who would benefit from earlier endoscopy referral.

eDIGEST

Currently Recruiting

Aims

  1. Develop a non-invasive diagnostic tool using breath biomarkers for OAC, OSCC and HNSCC
  2. Analyse biomarker profiles in multiple bio-samples comparing cancer patients to controls
  3. Determine diagnostic accuracy in a multicentre blind validation study

Methods

Multicentre case-control study with 300 participants divided equally between HNSCC, OAC/OSCC, and non-cancer controls. Breath samples collected using standardised procedures on TD tubes and analysed using mid-polar, polar, and 2D GC-MS-TOF. Collection of non-breath bio-samples (saliva, urine, blood, tissue) has completed recruitment.

Participating Centres

Participation

Recruitment to this trial takes place through participating NHS centres. If you think you may be eligible, please speak with your GP or hospital clinician who can refer you through the appropriate pathway.

Healthcare professional enquiries: Sameera Sharma · ssharma@ic.ac.uk

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