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

Last updated: January 29, 2025
Sponsor: Imperial College London
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastric Cancer

Esophageal Cancer

Treatment

Oral Stimulant Drink

Clinical Study ID

NCT05412758
21HH7100
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

AROMA 1 Inclusion Criteria:

  1. Aged 18-90years

  2. Oesophageal/gastric cancer cohort: participants with biopsy proven adenocarcinomawho are treatment naïve

  3. Control cohort: participants with normal or benign upper gastrointestinal diseasedetermined on: • Endoscopy within 1 year • Planned endoscopy

Exclusion

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 thelast 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, PotassiumChloride, 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 adenocarcinomawho are treatment naïve

  3. Oesophageal/gastric control cohort: participants with normal or benign uppergastrointestinal 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 cohortsonly)

  7. Active infection, on immunosuppressive medications or antibiotic therapy within thelast 8 weeks

  8. Participants with co-morbidities preventing breath collection

  9. Unable or unwilling to provide informed written consent

  10. Pregnant participants

Study Design

Total Participants: 648
Treatment Group(s): 1
Primary Treatment: Oral Stimulant Drink
Phase:
Study Start date:
February 28, 2022
Estimated Completion Date:
October 31, 2025

Study 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 patients, will be recruited: (i) oesophageal cancer (ii) gastric cancer and (iii) control/normal patients with upper gastrointestinal symptoms. After a baseline breath sample is collected, subjects will then be asked to consume a standard nutrient drink. Further breath samples will be collected at 0 and 15 minutes after consumption of the drink.

Breath samples will be stored on thermal desportion tubes before being transfered to a central laboratory for analysis. Breath samples will be analysed in accordance with existing quality-controlled processes. A combined approach of chromatographic- and real time- mass spectrometric techniques will be applied for VOC profiling.

BIORESOURCE: Samples from 335 patients will be collected in order to establish a biobank for multi-omic analyses. Three groups, each containing 75 patients, will be recruited: (i) oesophageal adenocarcinoma; (ii) gastric adenocarcinoma and (iii) oesophageal controls - benign conditions/normal gastrointestinal tract with upper gastrointestinal symptoms (iv) gastric controls - benign conditions/normal gastrointestinal tract with upper gastrointestinal symptoms. The following biosamples will be collected: breath, urine, saliva, blood, tissue and gastric contents. Collected samples will be utilised in a wide range of studies to investigate the mechanisms of VOC production in cancer. The following analyses will be performed: volatalomics, metabonomics/lipidomics, microbiome analysis, transcriptomics and cell culture experiments.

Connect with a study center

  • Imperial College NHS Foundation Trust

    London, W12 0HS
    United Kingdom

    Active - Recruiting

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