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

NCT05412758 | Recruiting

• 1 other identifier: 21HH7100
• Study Type: interventional
• Target: 648
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Efficacy of an oral nutrient drink to stimulate the production of volatile organic compounds detected in the breath.

  Efficacy of the oral stimulant drink will be measured by comparing the relative abundance of certain volatile organic compounds (measured in ppt) detected in the breath. Breath analysis will be performed with the help of Gas Chromatography- Mass Spectrometry (GC-MS)

  18 months

Secondary Outcomes (5)

• Volatile metabolites present in breath of subjects with oesophagogastric cancer and controls

  18 months

• Volatile metabolites present in headspace of the urine of subjects with oesophagogastric cancer and controls

  18 months

• Determination of bacterial species and cancer associated volatile compound production from saliva samples of subjects with oesophagogastric cancer.

  18 months

• Determination of bacterial species and cancer associated volatile compound production from tissue samples of subjects with oesophagogastric cancer

  18 months

• Determination of bacterial species and cancer associated volatile compound production from gastric contents of subjects with oesophagogastric cancer

  18 months

Study Arms (3)

Oesophageal/GOJ cancer

EXPERIMENTAL

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.

Dietary Supplement: Oral Stimulant Drink

Gastric cancer

EXPERIMENTAL

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.

Dietary Supplement: Oral Stimulant Drink

Control/ normal patients with upper gastrointestinal symptoms

EXPERIMENTAL

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.

Dietary Supplement: Oral Stimulant Drink

Interventions

Oral Stimulant Drink DIETARY_SUPPLEMENT

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

Also known as: Oral Nutrient Drink

Control/ normal patients with upper gastrointestinal symptoms; Gastric cancer; Oesophageal/GOJ cancer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Oesophageal squamous cell carcinoma
• Previous oesophageal and gastric resection
• Received neoadjuvant chemotherapy for oesophageal or gastric cancer
• History of another cancer within three years
• Any form of oesophageal dysplasia (control cohort only)
• Previously diagnosed with Barrett's oesophagus (control cohort only)
• Active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks
• Participants with co-morbidities preventing breath collection
• 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
• Unable or unwilling to provide informed written consent
• Pregnant participants
• 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
• Oesophageal squamous cell carcinoma

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator
• University Hospital Birmingham NHS Foundation Trust: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator
• Nottingham University Hospitals NHS Trust: collaborator
• University Hospital Plymouth NHS Trust: collaborator
• Royal Surrey County Hospital NHS Foundation Trust: collaborator
• University Hospitals Coventry and Warwickshire NHS Trust: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Portsmouth Hospitals NHS Trust: collaborator
• Barking, Havering and Redbridge University Hospitals NHS Trust: collaborator
• Northern Care Alliance NHS Foundation Trust: collaborator
• Brighton and Sussex University Hospitals NHS Trust: collaborator
• University College London Hospitals: collaborator
• Cardiff and Vale University Health Board: collaborator
• NHS Lothian: collaborator
• NHS Tayside: collaborator
• York Teaching Hospitals NHS Foundation Trust: collaborator
• The Harley Street Clinic: collaborator

Study Sites (1)

Imperial College NHS Foundation Trust

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• George Hanna, PhD, FRCS

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayushi Pabari, BSc, MSc

CONTACT

02075948847; aroma@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There are two arms to this study; AROMA 1 and BIORESOURCE. It is the AROMA 1 arm of the study that involves an intervention. 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 patients, will be recruited: (i) oesophageal cancer (ii) gastric cancer and (iii) control/normal patients with upper gastrointestinal symptoms. After the first baseline breath sample at 0 minutes is collected, subjects will then be asked to consume a standard nutrient drink. Further breath samples will be collected at 15 minutes after consumption of the drink.

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: June 9, 2022
• Study Start: February 28, 2022
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)