Clinical trial · Interventional
Augmentation of Volatile Biomarkers of Oesophageal and Gastric Adenocarcinoma From the Tumour Lipidome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Nearly 10,000 people die each year in the United Kingdom from cancer of the lower gullet and stomach, known as known as oesophago- gastric adenocarcinoma (OGC). OGC is detected late as symptoms are non- specific and often mistaken for common problems such as heartburn. This translates to fewer than 2 in every 10 patients diagnosed with OGC living longer than 5 years. The breath of people with OGC is enriched with volatile chemicals (VOCs) that indicate cancer. When measured in a breath test, it detects OAC 80 out of 100 times. Whilst encouraging, there is scope to improve the detection rate by giving patients a stimulant drink that amplifies the production of tumour specific VOCs only, to increase their detection in the breath test. The goal of this observational study is to produce an enhanced second-generation breath test with superior ability to detect OGC through augmentation of breath. This will improve long term survival from cancer using an entirely non- invasive test. All participants (cancer and control participants) will consume an oral stimulant drink (OSD) and provide breath samples pre and post consumption of the drink at set time points (maximum 2 hours after consumption of the drink). The investigators will compare the breath VOCs from both groups, before and after consumption of the OSD to see if the OSD has a desired augmentation effect and can improve the accuracy of the OGC breath test. With this second-generation breath test, participants with vague symptoms can undergo a quick, non- invasive test, have samples analysed in a safe and accurate manner and be subsequently stratified based on their risk of having OGC, leading to earlier disease detection and improved clinical outcomes.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Augmentation | — | UNRESOLVED | — |
| Breath Test | — | UNRESOLVED | — |
| Diagnoses Disease | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Oesophageal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Stimulant Drink | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oesophago- gastric adenocarcinoma patients
- description
- Oesophagogastric adenocarcinoma (OG) cancer patients (who are neoadjuvant chemotherapy treatment naïve) will receive 120mls of a sterile oral stimulant drink (OSD) (manufactured by Ingenza ltd), which is an ISO accredited laboratory. The active component of the drink is iron sulphate (5g/l), pH 5-6. Breath will be taken following an optimised methodology designed by the VOC laboratory at Imperial college London at baseline and then at 30, 60 and 90 minutes following consumption of the drink. Participants will be nil by mouth for 6 hours prior to the breath test, they can have water up to 2 hours before the breath test.
- interventionNames
- Dietary Supplement: Oral Stimulant Drink
- type
- ACTIVE_COMPARATOR
- label
- Benign healthy control patients
- description
- Age, gender and demographic matched patients who have had a negative oesophagogastroscopy within 1 year which is negative for adenocarcinoma will be recuited into the comparison arm. Patients will be given the same OSD and breath will be sampled at the same time points as the experimental arm.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Participants should be over 18 years old and up to the maximal age of 90 years , AND: * Have a confirmed histological diagnosis of oesophageal OR gastric adenocarcinoma at Imperial NHS Healthcare Trust, AND * Will undergo am oesophagogastroscopy (OGD) as part of their routine clinical care, OR: * Will undergo surgical resection of their oesophageal or gastric cancer as part of their routine clinical care OR * Any patient with non- cancerous upper gastrointestinal (benign) problem who will have an OGD OR surgery as part of their routine clinical care at Imperial NHS Trust Exclusion Criteria: * Participant that lacks capacity or is unable to provide informed consent * Any participant below 18 years of age or over 90 years of age * Participants with allergies to any aspect of the metabolic drink * Participants who have had previous OG surgical resection
References
Publications (3)
- BACKGROUNDMitra A, Choi S, Boshier PR, Razumovskaya-Hough A, Belluomo I, Spanel P, Hanna GB. The Human Skin Volatolome: A Systematic Review of Untargeted Mass Spectrometry Analysis. Metabolites. 2022 Sep 1;12(9):824. doi: 10.3390/metabo12090824. PMID 36144228
- RESULTMarkar SR, Wiggins T, Antonowicz S, Chin ST, Romano A, Nikolic K, Evans B, Cunningham D, Mughal M, Lagergren J, Hanna GB. Assessment of a Noninvasive Exhaled Breath Test for the Diagnosis of Oesophagogastric Cancer. JAMA Oncol. 2018 Jul 1;4(7):970-976. doi: 10.1001/jamaoncol.2018.0991. PMID 29799976
- RESULTAntonowicz S, Bodai Z, Wiggins T, Markar SR, Boshier PR, Goh YM, Adam ME, Lu H, Kudo H, Rosini F, Goldin R, Moralli D, Green CM, Peters CJ, Habib N, Gabra H, Fitzgerald RC, Takats Z, Hanna GB. Endogenous aldehyde accumulation generates genotoxicity and exhaled biomarkers in esophageal adenocarcinoma. Nat Commun. 2021 Mar 5;12(1):1454. doi: 10.1038/s41467-021-21800-5. PMID 33674602