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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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

+44 (0) 207 594 8847

henry.robb19@imperial.ac.uk

United Kingdom1 site, 1 recruiting
  • Imperial College NHS Healthcare Trust

    London

    Henry Robb, MBChB BSc (Hons) MSc MRCS, 44 (0) 207 594 8847

    Recruiting

Other trials in United Kingdom

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.

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 groups in NCT06669663
Study groupRoleWhat they receive
Pimonidazole GroupWill receive Pimonidazole (as a non-CTIMP) to enable hypoxic tumour stratification
Receives: Drug: Pimonidazole hydrochloride (Hypoxyprobe™-1)
Biosampling GroupParticipants 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.

  1. 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

  2. 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.

  1. First posted1 Nov 2024
  2. Study start1 Sep 2024
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Aug 2028 (estimated)

Resources

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)
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

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.

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