Status:

RECRUITING

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

Lead Sponsor:

Imperial College London

Collaborating Sponsors:

Imperial College Healthcare NHS Trust

Newcastle-upon-Tyne Hospitals NHS Trust

Conditions:

Volatile Organic Compounds

Microbiome

Eligibility:

All Genders

18-90 years

Phase:

NA

Brief 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 ...

Detailed Description

AROMA 1: A total of 648 patients will be recruited for development of an augmented breath test to detect oesophageal and gastric cancer at early stages of disease. Three groups, each containing 216 pa...

Eligibility Criteria

AROMA 1 Inclusion Criteria:

  1. Aged 18-90years
  2. Oesophageal/gastric cancer cohort: participants with biopsy proven adenocarcinoma who are treatment naïve
  3. Control cohort: participants with normal or benign upper gastrointestinal disease determined on: • Endoscopy within 1 year • Planned endoscopy

AROMA 1 Exclusion criteria:

Patients with the following characteristics will not be eligible for inclusion in this study:

  1. Oesophageal squamous cell carcinoma
  2. Previous oesophageal and gastric resection
  3. Received neoadjuvant chemotherapy for oesophageal or gastric cancer
  4. History of another cancer within three years
  5. Any form of oesophageal dysplasia (control cohort only)
  6. Previously diagnosed with Barrett's oesophagus (control cohort only)
  7. Active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks
  8. Participants with co-morbidities preventing breath collection
  9. Allergies to any of the constituents of the nutrient drink including glucose, glycerol, iron sulphate, Maltodextrin (Corn, Potato), Xanthan Gum, Potassium Chloride, tyrosine, phenylalanine, and glutamic acid
  10. Unable or unwilling to provide informed written consent
  11. Pregnant participants

BIORESOURCE inclusion criteria:

  1. Aged 18- 90years
  2. Oesophageal/gastric cancer cohort: participants with biopsy proven adenocarcinoma who are treatment naïve
  3. Oesophageal/gastric control cohort: participants with normal or benign upper gastrointestinal disease determined on: • Planned endoscopy

BIORESOURCE exclusion criteria:

  1. Oesophageal squamous cell carcinoma
  2. Previous oesophageal and gastric resection
  3. Received neoadjuvant chemotherapy for oesophageal or gastric cancer
  4. History of another cancer within five years
  5. Any form of oesophageal dysplasia (oesophageal/gastric control cohorts only)
  6. Previously diagnosed with Barrett's oesophagus (oesophageal/gastric control cohorts only)
  7. Active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks
  8. Participants with co-morbidities preventing breath collection
  9. Unable or unwilling to provide informed written consent
  10. Pregnant participants

Key Trial Info

Start Date :

February 28 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2025

Estimated Enrollment :

648 Patients enrolled

Trial Details

Trial ID

NCT05412758

Start Date

February 28 2022

End Date

October 1 2025

Last Update

January 31 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Imperial College NHS Foundation Trust

London, United Kingdom, W12 0HS