RecruitingOBSERVATIONAL

Hypoxia Driven Metabolic Response in Oesophagogastric Adenocarcinoma

This research is looking into a new breath test for oesophageal and stomach cancers. These cancers can be challenging to treat, partly because some tumours have low oxygen levels, which makes them more aggressive and harder to deal with. Currently, there isn't an easy way to spot these low-oxygen tumours. This study, called HYDRA, aims to create a non-invasive breath test to identify them. If successful, this test could help doctors better understand a patient's cancer and guide them towards more effective, personalised treatments.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

120

Start

01 Sep 2024

Estimated completion

01 Aug 2028

OESOPHAGO-GASTRIC CARCINOMA

What is this study about?

Oesophageal (gullet) and stomach cancers are serious conditions, and unfortunately, survival rates in the UK can be low. One reason for this is that some of these cancers have areas with very low oxygen, called "hypoxia." When a cancer grows quickly, it can outstrip its blood supply, meaning not enough oxygen reaches certain parts of the tumour. These low-oxygen areas can make the cancer more aggressive and harder to treat with standard therapies. Currently, doctors don't have a simple way to figure out if a patient's tumour has these low-oxygen areas without taking a biopsy, which is an invasive procedure.

This study, called HYDRA, is trying to solve this problem by developing a new, non-invasive breath test. Researchers at Imperial College London have already had success developing breath tests to diagnose these cancers, and they believe they can adapt this technology to detect low-oxygen tumours. The idea is that low-oxygen tumours might release specific chemicals into the breath that can be detected. If a reliable breath test can be developed, it would be a huge step forward.

Being able to identify patients with low-oxygen tumours would be very helpful because there are new, targeted treatments being developed that specifically work against these types of cancers. By knowing if a tumour is low in oxygen, doctors could potentially offer more personalised and effective treatments, leading to better outcomes for patients. This study will involve two main parts: one using a special marker to identify low-oxygen areas in tumour samples, and another collecting breath and tumour samples from more patients to refine and develop the breath test.

Key takeaways

This study aims to develop a new breath test for oesophageal and stomach cancers.
The test will look for signs of 'hypoxia' (low oxygen) in tumours.
Identifying hypoxia could help doctors offer more targeted and effective treatments.
Participation involves either a small injection and sample analysis, or breath/tumour sample collection and analysis.
The study is observational and will not change your immediate cancer treatment.
It aims to improve care for future patients with similar cancers.

Who may be eligible?

This study is looking for both men and women between the ages of 18 and 90. To take part, you must have been diagnosed with oesophageal or stomach adenocarcinoma (a specific type of cancer) and be scheduled for surgery or a staging laparoscopy (an exploratory operation).

There are some reasons why you might not be able to join. For example, if your cancer is not adenocarcinoma, if you've recently taken antibiotics (within the last 8 weeks), or if you've had previous surgery on your oesophagus or stomach, you won't be eligible. Also, if you're allergic to a substance called pimonidazole (which some participants will receive), or if you are pregnant, you cannot take part.

Finally, you need to be able to fully understand the study and agree to participate by giving your written consent. Your medical team will help you understand all the details if you're interested.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 90 years old?
Have you been diagnosed with oesophageal or stomach adenocarcinoma?
Are you scheduled for surgery or an exploratory operation for your cancer?
Have you *not* taken antibiotics in the last 8 weeks?
Have you *not* had previous oesophageal or stomach surgery?
Are you able to understand and sign a consent form?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the exact steps will depend on which part of the study you join. In one part, for 20 participants, you would receive a small injection of a special dye called pimonidazole a few hours before your planned surgery for oesophageal or stomach cancer. This dye helps highlight the low-oxygen areas in the tumour. During your surgery, tissue samples will be collected as usual, but these will then be specially analysed to identify the specific features of low-oxygen tumours. Your participation in this part of the study would involve this injection and allowing the extra analysis of your surgical samples.

In the second, larger part of the study (for 100 participants), you would have breath samples taken before your surgery for oesophageal or stomach cancer. During your surgery, your medical team will also collect tumour samples as part of your normal procedure. These breath samples and tumour samples will then be analysed by the research team. This means your participation would involve providing breath samples and allowing the extra analysis of your surgical samples. There are no additional visits required beyond your normal hospital appointments for either part of the study, and your involvement will be completed once your samples have been collected and analysed.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information gained is vital for developing better ways to treat oesophageal and stomach cancers in the future. If a successful breath test for low-oxygen tumours can be created, it could help many other patients get more effective, personalised care. For those receiving pimonidazole, there's a very small risk of an allergic reaction, which your medical team will discuss with you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Imperial College NHS Healthcare Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'hypoxia' in cancer?

Hypoxia means there's a low level of oxygen in parts of the cancer tumour. This can make the cancer more aggressive and harder to treat.

Why is a breath test important?

A breath test is a simple, non-invasive way to gather information about your cancer without needing a biopsy or other procedures. It's much more comfortable for patients.

Will taking part change my cancer treatment?

No, your participation in this study will not directly change your current treatment plan. The goal is to develop tools for future patients.

Is pimonidazole safe?

Pimonidazole is a dye that has been used in previous research studies. Your medical team will discuss any potential, very rare, side effects or risks with you in detail.

What happens to my samples after the study?

Your biological samples will be used only for the research described in this study, and any genetic information will be kept confidential and anonymised as much as possible.

How to find out more

Henry Douglas Robb, MBChB BSc (Hons) MSc MRCS

henry.robb19@imperial.ac.uk +44 (0) 207 594 8847 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.