OESOPHAGO-GASTRIC CARCINOMAHYDRANCT06669663
Hypoxia Driven Metabolic Response in Oesophagogastric Adenocarcinoma
An observational study of OESOPHAGO-GASTRIC CARCINOMA, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Oesophagogastric Cancer and Hypoxia: Oesophagogastric cancer is a significant global burden, with 1.7 million new cases per year. It is well known that survival from oesophagogastric cancer is poor. Five-year survival for these cancers in the UK remains between 15-20%, which is amongst the lowest in Europe. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- OESOPHAGO-GASTRIC CARCINOMA
- What is being tested?
- Pimonidazole hydrochloride (Hypoxyprobe™-1)
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2024to 1 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oesophago-gastric patients undergoing surgery on their cancer
Who may be able to join
- Male and females aged 18-90 years.
- Patients with biopsy proven oesophageal or gastric adenocarcinoma who are undergoing either surgical resection or staging laparoscopy.
Who cannot join
- Non-adenocarcinoma cancer (e.g. oesophageal squamous cell carcinoma)
- Antibiotic therapy within the last 8 weeks
- Previous oesophageal and gastric resection
- Allergy to pimonidazole
- Unable or unwilling to provide informed written consent
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Henry Douglas Robb, MBChB BSc (Hons) MSc MRCS contact
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College NHS Healthcare Trust
London
Henry Robb, MBChB BSc (Hons) MSc MRCS, 44 (0) 207 594 8847
About this study
Oesophagogastric Cancer and Hypoxia:
Oesophagogastric cancer is a significant global burden, with 1.7 million new cases per year. It is well known that survival from oesophagogastric cancer is poor. Five-year survival for these cancers in the UK remains between 15-20%, which is amongst the lowest in Europe. The reason for this poor survival is multifactorial, with late diagnosis and treatment-resistant hypoxic tumours both significantly contributing to this high mortality.
Read more
Tumour hypoxia occurs when rapidly growing malignancies outstrip oxygen (and nutrient) supply. These hypoxic conditions trigger adaptive metabolic and genomic mutations within the cancer. Clinically, these mutations lead to cancers which are highly aggressive and treatment resistant. Therefore, patients with oesophagogastric cancers displaying high degrees of hypoxia have a considerably poorer prognosis. Reassuringly, there are emerging treatment options available. The adaptive pathways triggered by hypoxia offer unique opportunities for personalized and targeted oncological therapies to improve clinical outcomes in this patient cohort. However, for these therapies to be effective, it is vital patients with hypoxic tumours can be identified.
There are currently no established methods for identifying hypoxic tumours in oesophagogastric cancer patients. Whilst biomarker candidates have been identified, these require invasive biopsies and are limited in terms of repeatability, and therefore clinical applicability. There is hope in developing non-invasive hypoxic imaging, however considerable validation work is required prior to their clinical introduction for oesophagogastric patients.
Volatile Organic Compounds and Breath:
The Hanna Group at Imperial College London has developed a non-invasive breath test for the diagnosis of oesophagogastric adenocarcinoma through the detection of exhaled Volatile Organic Compounds (VOCs). This was validated in a multi-centre NIHR-funded clinical study that demonstrated 80% sensitivity and 81% specificity. In parallel with this work, the exhalation kinetics and molecular drivers of VOCs in oesophagogastric adenocarcinoma have also been investigated. It has been understood that the VOCs that can be detected in blood, breath, urine, and saliva are a representation of the metabolic and microbiotic changes that occur in the tumour and its microenvironment.
Rationale for Study:
There is a clear unmet need for a dynamic non-invasive test to identify patients suffering with hypoxic oesophagogastric tumours. By adapting the breath test model, it is believed that patients with hypoxic tumours can be effectively detected. This creates the opportunity to offer targeted oncological therapies for these patients. Furthermore, the reproducibility and patient acceptability make a breath test an ideal testing method for dynamic hypoxia monitoring .
Promising work within the Hanna Group has already demonstrated the potential viability of a 'hypoxia breath test'. Early cell culture experiments and pilot studies have demonstrated hypoxic tumours release discriminatory VOCs which could be leveraged as hypoxic biomarkers.
HYDRA Study
The HYDRA study is a single-centre observational study at Imperial College London with the aim of devising a non-invasive breath test for OG tumour hypoxia. The study contains two arms: the Pimonidazole and Biosampling arm.
In the Pimonidazole arm, 20 participants (10 oesophageal and 10 gastric cancer) will be given Pimonidazole (Hypoxyprobe Inc.), a hypoxia-labelling agent, prior to their surgery for oesophagogastric cancer. Hypoxia-stratified tissue will be sampled intraoperatively and analysed using spatial transcriptomics and spatial metabolomic techniques. This will allow the creation of an OG-hypoxic gene signature.
The Biosampling arm will recruit 100 patients undergoing OG cancer surgery. Participants will undergo breath sampling and intra-operative tumour sampling. Using the hypoxic gene signature generated in the Pimonidazole arm, transcriptomic analysis of tumour samples will allow patient categorisation into hypoxia-high and hypoxia-low subgroups. This will enable our group to devise a hypoxic OG breath test, separating patients with hypoxia-high and hypoxia-low tumours.
- Conditions
- OESOPHAGO-GASTRIC CARCINOMA
- Being tested
- Pimonidazole hydrochloride (Hypoxyprobe™-1)
- Keywords
- voc, hypoxia, pimonidazole, oesophago-gastric carcinoma, volatile organic compounds, breath test
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pimonidazole hydrochloride (Hypoxyprobe™-1)Drug
Participants will receive Pimonidazole (non-CTIMP) prior to their surgery for OG cancer and then undergo intra-operative sampling.
| Study group | Role | What they receive |
|---|---|---|
| Pimonidazole Group | Will receive Pimonidazole (as a non-CTIMP) to enable hypoxic tumour stratification Receives: Drug: Pimonidazole hydrochloride (Hypoxyprobe™-1) | |
| Biosampling Group | Participants will undergo blood, urine and breath sampling on their morning of their surgery on their OG tumour. Intra-operatively, tumour samples will be taken. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxic Gene Signature
Spatial transcriptomic, lipidomic and pathway analysis on pimonidazole-labelled tissue will allow the identification of a OAC hypoxic gene signature.
Measured: 5 years
Volatile Organic Compounds Breath Signature
Bulk RNAseq will be performed on tumour samples from Biosampling participants. Participants will then be classified by their hypoxic score using the previously derived hypoxic gene signature. Distinguishing Volatile Organic Compounds (VOCs) detected in exhaled breath, using GC-MS, between these two groups will generate an OAC hypoxic breath profile.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Sep 2024
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OESOPHAGO-GASTRIC CARCINOMAStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George Hanna, Principal investigator, Imperial College LondonHenry Robb, MBChB BSc (Hons) MSc MRCS, Study director, Imperial College LondonBibek Das, MBChB, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669663
- Sponsor's protocol ID
- 324771
- Other IDs
- MR/Z504142/1, 23/PR/0723
- Acronym
- HYDRA
- Status last verified
- Mar 2025
- First submitted
- 30 Oct 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxia Driven Metabolic Response in Oesophagogastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06669663
- Acronym / sponsor ID
- HYDRA / 324771
- Conditions
- OESOPHAGO-GASTRIC CARCINOMA
- Keywords
- voc, hypoxia, pimonidazole, oesophago-gastric carcinoma, volatile organic compounds, breath test
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oesophagogastric Cancer and Hypoxia:
Oesophagogastric cancer is a significant global burden, with 1.7 million new cases per year. It is well known that survival from oesophagogastric cancer is poor. Five-year survival for these cancers in the UK remains between 15-20%, which is amongst the lowest in Europe. The reason for this poor survival is multifactorial, with late diagnosis and treatment-resistant hypoxic tumours both significantly contributing to this high mortality.
Tumour hypoxia occurs when rapidly growing malignancies outstrip oxygen (and nutrient) supply. These hypoxic conditions trigger adaptive metabolic and genomic mutations within the cancer. Clinically, these mutations lead to cancers which are highly aggressive and treatment resistant. Therefore, patients with oesophagogastric cancers displaying high degrees of hypoxia have a considerably poorer prognosis. Reassuringly, there are emerging treatment options available. The adaptive pathways triggered by hypoxia offer unique opportunities for personalized and targeted oncological therapies to improve clinical outcomes in this patient cohort. However, for these therapies to be effective, it is vital patients with hypoxic tumours can be identified.
There are currently no established methods for identifying hypoxic tumours in oesophagogastric cancer patients. Whilst biomarker candidates have been identified, these require invasive biopsies and are limited in terms of repeatability, and therefore clinical applicability. There is hope in developing non-invasive hypoxic imaging, however considerable validation work is required prior to their clinical introduction for oesophagogastric patients.
Volatile Organic Compounds and Breath:
The Hanna Group at Imperial College London has developed a non-invasive breath test for the diagnosis of oesophagogastric adenocarcinoma through the detection of exhaled Volatile Organic Compounds (VOCs). This was validated in a multi-centre NIHR-funded clinical study that demonstrated 80% sensitivity and 81% specificity. In parallel with this work, the exhalation kinetics and molecular drivers of VOCs in oesophagogastric adenocarcinoma have also been investigated. It has been understood that the VOCs that can be detected in blood, breath, urine, and saliva are a representation of the metabolic and microbiotic changes that occur in the tumour and its microenvironment.
Rationale for Study:
There is a clear unmet need for a dynamic non-invasive test to identify patients suffering with hypoxic oesophagogastric tumours. By adapting the breath test model, it is believed that patients with hypoxic tumours can be effectively detected. This creates the opportunity to offer targeted oncological therapies for these patients. Furthermore, the reproducibility and patient acceptability make a breath test an ideal testing method for dynamic hypoxia monitoring .
Promising work within the Hanna Group has already demonstrated the potential viability of a 'hypoxia breath test'. Early cell culture experiments and pilot studies have demonstrated hypoxic tumours release discriminatory VOCs which could be leveraged as hypoxic biomarkers.
HYDRA Study
The HYDRA study is a single-centre observational study at Imperial College London with the aim of devising a non-invasive breath test for OG tumour hypoxia. The study contains two arms: the Pimonidazole and Biosampling arm.
In the Pimonidazole arm, 20 participants (10 oesophageal and 10 gastric cancer) will be given Pimonidazole (Hypoxyprobe Inc.), a hypoxia-labelling agent, prior to their surgery for oesophagogastric cancer. Hypoxia-stratified tissue will be sampled intraoperatively and analysed using spatial transcriptomics and spatial metabolomic techniques. This will allow the creation of an OG-hypoxic gene signature.
The Biosampling arm will recruit 100 patients undergoing OG cancer surgery. Participants will undergo breath sampling and intra-operative tumour sampling. Using the hypoxic gene signature generated in the Pimonidazole arm, transcriptomic analysis of tumour samples will allow patient categorisation into hypoxia-high and hypoxia-low subgroups. This will enable our group to devise a hypoxic OG breath test, separating patients with hypoxia-high and hypoxia-low tumours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pimonidazole Group | – | Drug: Pimonidazole hydrochloride (Hypoxyprobe™-1)Will receive Pimonidazole (as a non-CTIMP) to enable hypoxic tumour stratification |
| Biosampling Group | – | –Participants will undergo blood, urine and breath sampling on their morning of their surgery on their OG tumour. Intra-operatively, tumour samples will be taken. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oesophago-gastric patients undergoing surgery on their cancer
Key inclusion criteria (2 listed)
- Male and females aged 18-90 years.
- Patients with biopsy proven oesophageal or gastric adenocarcinoma who are undergoing either surgical resection or staging laparoscopy.
Key exclusion criteria (6 listed)
- Non-adenocarcinoma cancer (e.g. oesophageal squamous cell carcinoma)
- Antibiotic therapy within the last 8 weeks
- Previous oesophageal and gastric resection
- Allergy to pimonidazole
- Unable or unwilling to provide informed written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pimonidazole hydrochloride (Hypoxyprobe™-1)Participants will receive Pimonidazole (non-CTIMP) prior to their surgery for OG cancer and then undergo intra-operative sampling. | Drug | Pimonidazole Group |
Primary outcome
Hypoxic Gene Signature
Time frame: 5 years
Spatial transcriptomic, lipidomic and pathway analysis on pimonidazole-labelled tissue will allow the identification of a OAC hypoxic gene signature.
Volatile Organic Compounds Breath Signature
Time frame: 5 years
Bulk RNAseq will be performed on tumour samples from Biosampling participants. Participants will then be classified by their hypoxic score using the previously derived hypoxic gene signature. Distinguishing Volatile Organic Compounds (VOCs) detected in exhaled breath, using GC-MS, between these two groups will generate an OAC hypoxic breath profile.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Henry Douglas Robb, MBChB BSc (Hons) MSc MRCS contact
George Hanna principal investigator
Imperial College London
Henry Robb, MBChB BSc (Hons) MSc MRCS study director
Imperial College London
Bibek Das, MBChB study chair
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OESOPHAGO-GASTRIC CARCINOMA, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henry Douglas Robb, MBChB BSc (Hons) MSc MRCS (+44 (0) 207 594 8847, henry.robb19@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxic Gene Signature (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.