Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
Healthy Volunteers
NCT05412758

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

Led by Imperial College London · Updated on 2025-01-31

648

Participants Needed

1

Research Sites

187 weeks

Total Duration

On this page

Sponsors

I

Imperial College London

Lead Sponsor

I

Imperial College Healthcare NHS Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 90 years
  • Participants with biopsy-proven adenocarcinoma of the esophagus or stomach who are treatment-naive (for cancer cohorts)
  • Participants with normal or benign upper gastrointestinal disease confirmed by endoscopy within 1 year or with planned endoscopy (for control cohorts)
Not Eligible

You will not qualify if you...

  • Diagnosis of esophageal squamous cell carcinoma
  • Previous surgery removing part of the esophagus or stomach
  • Received neoadjuvant chemotherapy for esophageal or gastric cancer
  • History of another cancer within 3 years (AROMA 1) or 5 years (BIORESOURCE)
  • Any form of esophageal dysplasia (control cohorts)
  • Previously diagnosed Barrett's esophagus (control cohorts)
  • Active infection, use of immunosuppressive medication, or antibiotic therapy within the last 8 weeks
  • Co-morbidities preventing breath collection
  • Allergies to any ingredients of the nutrient drink including glucose, glycerol, iron sulphate, maltodextrin (corn, potato), xanthan gum, potassium chloride, tyrosine, phenylalanine, and glutamic acid (AROMA 1 only)
  • Unable or unwilling to provide informed written consent
  • Pregnant participants

AI-Screening

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Trial Site Locations

Total: 1 location

1

Imperial College NHS Foundation Trust

London, United Kingdom, W12 0HS

Actively Recruiting

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Research Team

A

Ayushi Pabari, BSc, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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