Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Cancer of the stomach and oesophagus is among the world's top five cancers. Survival rates are very poor as the disease presents late and early symptoms are non-specific. The study team has developed a non-invasive test for cancers of the stomach and oesophagus based on the detection of volatile organic compounds in exhaled breath. These compounds are known to be produced by both cancers as well as cancer associated bacteria within the gut. The proposed innovation is to improve the accuracy of this test by investigating whether simple metabolic substrates can increase the production of these volatile organic compounds by both the tumour and its associated bacteria.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• Aged 18-90years

• Oesophageal/gastric cancer cohort: participants with biopsy proven adenocarcinoma who are treatment naïve

• Control cohort: participants with normal or benign upper gastrointestinal disease determined on: • Endoscopy within 1 year • Planned endoscopy

• Aged 18- 90years

• Oesophageal/gastric cancer cohort: participants with biopsy proven adenocarcinoma who are treatment naïve

• Oesophageal/gastric control cohort: participants with normal or benign upper gastrointestinal disease determined on: • Planned endoscopy

Locations
Other Locations
United Kingdom
Imperial College NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Ayushi Pabari, BSc, MSc
aroma@imperial.ac.uk
02075948847
Time Frame
Start Date: 2022-02-28
Estimated Completion Date: 2025-10
Participants
Target number of participants: 648
Treatments
Experimental: Oesophageal/GOJ cancer
AROMA 1: 216 treatment naive patients with oesophageal/GOJ cancer will be recruited to undertake an augmented breath test.~BIORESOURCE: 110 treatment naive patients with oesophageal/GOJ cancer will be recruited for biosample collection at the time of their staging laparoscopy procedure.
Experimental: Gastric cancer
AROMA 1: 216 treatment naive patients with gastric cancer will be recruited to undertake an augmented breath test.~BIORESOURCE: 75 treatment naive patients with gastric cancer will be recruited for biosample collection at the time of their staging laparoscopy procedure.
Experimental: Control/ normal patients with upper gastrointestinal symptoms
AROMA 1: 216 control subjects will be recruited to undertake an augmented breath test.~BIORESOURCE: 150 control subjects will be recruited for biosample collection at the time of their routine endoscopy procedure.
Related Therapeutic Areas
Sponsors
Collaborators: University Hospitals Coventry and Warwickshire NHS Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, Portsmouth Hospitals NHS Trust, University Hospital Birmingham NHS Foundation Trust, York Teaching Hospitals NHS Foundation Trust, NHS Tayside, Nottingham University Hospitals NHS Trust, Northern Care Alliance NHS Foundation Trust, Imperial College Healthcare NHS Trust, The Harley Street Clinic, Guy's and St Thomas' NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust, Royal Surrey County Hospital NHS Foundation Trust, NHS Lothian, University College London Hospitals, Cardiff and Vale University Health Board, University Hospital Plymouth NHS Trust, Barking, Havering and Redbridge University Hospitals NHS Trust
Leads: Imperial College London

This content was sourced from clinicaltrials.gov