Augmentation of Volatile Biomarkers of Oesophageal and Gastric Adenocarcinoma From the Tumour Lipidome
AVOCADO
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2022
CompletedFirst Posted
Study publicly available on registry
October 31, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2023
CompletedNovember 2, 2022
October 1, 2022
5 months
October 25, 2022
October 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To establish a second- generation augmented breath test with improved diagnostic accuracy for the detection of OG adenocarcinoma.
This breath test will utilise serial breath sampling following the ingestion of an augmentation solution (OSD). Breath samples will be taken pre and post consumption of the OSD and fold changes in the VOCs will be calculated. The entire process of breath sampling is non- invasive.
12 months
To determine the diagnostic accuracy of the augmented exhaled breath test, in the prediction of oesophago-gastric cancer (OGC).
The investigators will generate an untargeted VOC breath model following exhaled VOC augmentation.
12 months
Secondary Outcomes (2)
To comprehensively characterise the tissue lipid input and lipidomic reprogramming in oesophagaeal and gastric adenocarcinoma in comparison to healthy non- cancer tissues.
deadline December 2022
To identify the mechanistic pathways and origins of the production of breath Volatile compounds by investigating the tumour lipidome.
12 months
Study Arms (2)
Oesophago- gastric adenocarcinoma patients
EXPERIMENTALOesophagogastric 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.
Benign healthy control patients
ACTIVE COMPARATORAge, 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.
Interventions
please see description of the drink in the arm/ group section
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anuja Mitralead
- British Medical Research Councilcollaborator
- British Association of Surgical Oncologycollaborator
- The Royal College of Surgeons of Englandcollaborator
Study Sites (1)
Volatile Biomarker Group, Commonwealth Building, Hammersmith Hospital, Imperial College London
London, W120NN, United Kingdom
Related Publications (3)
Mitra 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: 36144228BACKGROUNDMarkar 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: 29799976RESULTAntonowicz 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: 33674602RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George B Hanna, FMedSci
Imperial College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr, MRC Clinical Research fellow
Study Record Dates
First Submitted
October 25, 2022
First Posted
October 31, 2022
Study Start
November 1, 2022
Primary Completion
April 1, 2023
Study Completion
December 20, 2023
Last Updated
November 2, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- 3 years after the study has completed recruitment (December 2026). The information will be available for sharing for 2 years after that (until December 2028).
- Access Criteria
- Decisions to supply research data to new users will be made by: Dr Anuja Mitra, Professor Griffin and Professor Hanna (PI).
Metabolomic and experimental data will be shared as participants will be given a unique identifier rendering the information anonymous. All other data collated will be stored in a central secure repository under an embargo and will be suitable for sharing following approval by the Chief Investigator. New users can access a simple study policy and summarised data on the Imperial Clinical Research Network study website. Research data will also be discovered on the NIHR In-Vitro Diagnostic Co-operative website. Data will be disseminated through presentation at leading conferences that are accessible to subject specific and generalist audiences. Publication in high impact journals will allow global discovery of data to new users. Decisions to supply research data to new users will be made by: Dr Anuja Mitra, Professor Griffin and Professor Hanna (PI).