AUGMENTED RESPONSE OF VOLATILE BIOMARKERS IN THE ASSESSMENT OF OESOPHAGOGASTRIC CANCER (AROMA2)

NCT07260734 | Not Yet Recruiting DMC

• 1 other identifier: 353374
• Study Type: observational
• Target: 6,000
• Locations: 0 countries
• Sites: N/A

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

OESOPHAGO-GASTRIC CARCINOMA; Oesophageal Adenocarcinoma; Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma; Oesophageal Cancer Nos; Oesophageal Cancer; Oesophageal Junction Cancer; Breath Tests; Volatile Organic Compound

Keywords

Oesophageal adenocarcinoma; Gastric adenocarcinoma; Breath testing; Microbiome; Augmentation; Volatile Organic Compounds; Volatilomics; Breathomics

Outcome Measures

Primary Outcomes (1)

• Validation of VOC biomakrer model for Upper GI Adenocarcinoma

  GC-MS will be used to confirm the presence of upper gastrointestinal cancer-associated VOCs in order to validate the detection model developed in AROMA1

  3 years

Study Arms (1)

Participants referred along upper gastrointestinal suspected cancer pathways

Participants referred by GPs to secondary care for the reference test (i.e. upper gastrointestinal endoscopy, CT/MRI/ultrasound ± histological/cytology). Participants will be followed up (within 3 months) to determine whether they had a diagnosis of upper gastrointestinal adenocaricinoma or a normal/benign diagnosis.

Diagnostic Test: Breath Test

Interventions

Breath Test DIAGNOSTIC_TEST

Diagnostic Test: Breath test Participants must be fasted for a minimum of six hours prior to breath sample collection. Breath samples will be collected prior to the reference test for each participant. Participants will then be asked to consume an Oral Stimulant Drink (OSD). The oral stimulant drink (120ml) will be composed of 25g glucose, 25g glycerol, 0.6g iron sulphate, 1.2g of "Thicken Up" thickener and combined amino acids (0.08g tyrosine, 1.8g phenylalanine, 2.1g glutamic acid). Diagnostic Test: Augmented breath test: Participants will then be asked to repeat a breath sample 15 minutes after consumption of the OSD.

Participants referred along upper gastrointestinal suspected cancer pathways

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals aged 18 years or over with suspected cancer, referred from primary care for further specialized investigations.

You may qualify if:

• Aged ≥ 18 years old.
• Participants referred from primary care according to the urgent suspected cancer referral guidelines for potential underlying oesophagogastric cancer a for the reference test (described below).
• Willing and able to provide informed written consent to take part in study.

You may not qualify if:

• Previous oesophageal or gastric resection
• History of cancer within three years (other than non-melanoma skin cancers)
• Co-morbidities preventing breath collection
• Pregnant participants
• 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.

Sponsors & Collaborators

• Imperial College London: lead

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breath

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus; Esophageal Neoplasms

Interventions

Breath Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• George Hanna

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayushi Pabari, BSc, MSc

CONTACT

02075948847; aroma@imperial.ac.uk

Nader Bedwani, MB BCHir, MRCS

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share