Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer (AROMA 1 / BIORESOURCE)

NCT05412758 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 648

Last updated 2025-01-31

No results posted yet for this study

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.

Conditions

  • Volatile Organic Compounds
  • Microbiome
  • Microbioata
  • Breath Analysis
  • Oesophageal Cancer
  • Gastric Cancer
  • Volatalomics
  • Metabonomics/Lipidomics
  • Microbiome Analysis
  • Transcriptomics

Interventions

DIETARY_SUPPLEMENT

Oral Stimulant Drink

For the AROMA 1 study patients will be requested to consume a nutrient drink (approximately 200 ml) that includes natural ingredients found within a typical human diet. Following consumption of the drink, serial breath tests will be performed to determine varying levels of VOC production in breath

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    collaborator OTHER
  • Newcastle-upon-Tyne Hospitals NHS Trust

    collaborator OTHER
  • University Hospital Birmingham NHS Foundation Trust

    collaborator OTHER
  • University Hospital Southampton NHS Foundation Trust

    collaborator OTHER
  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    collaborator OTHER
  • Nottingham University Hospitals NHS Trust

    collaborator OTHER
  • University Hospital Plymouth NHS Trust

    collaborator OTHER
  • Royal Surrey County Hospital NHS Foundation Trust

    collaborator OTHER
  • University Hospitals Coventry and Warwickshire NHS Trust

    collaborator OTHER
  • Guy's and St Thomas' NHS Foundation Trust

    collaborator OTHER
  • Portsmouth Hospitals NHS Trust

    collaborator OTHER_GOV
  • Barking, Havering and Redbridge University Hospitals NHS Trust

    collaborator OTHER
  • Northern Care Alliance NHS Foundation Trust

    collaborator OTHER
  • Brighton and Sussex University Hospitals NHS Trust

    collaborator OTHER
  • University College London Hospitals

    collaborator OTHER
  • Cardiff and Vale University Health Board

    collaborator OTHER_GOV
  • NHS Lothian

    collaborator OTHER_GOV
  • NHS Tayside

    collaborator OTHER_GOV
  • York Teaching Hospitals NHS Foundation Trust

    collaborator OTHER
  • The Harley Street Clinic

    collaborator OTHER
  • Imperial College London

    lead OTHER

Principal Investigators

  • George Hanna, PhD, FRCS · Imperial College London

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2025-07-31
Completion
2025-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05412758 on ClinicalTrials.gov