Active not recruitingOBSERVATIONAL

Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors

This study is for people in the UK who have had surgery for gullet (oesophageal) cancer. We want to understand why some survivors have ongoing symptoms after treatment. Researchers will look at germs in your gut (your microbiome) by checking samples of your saliva, poo, blood, and wee. We're also trying to develop a simple breath test to spot changes in these gut germs. The main goal is to find better ways to treat gut issues and improve the overall well-being and quality of life for gullet cancer survivors. Your participation could help us develop new treatments and diagnostic tools.

At a glance

Status

Active not recruiting

Sponsor

Imperial College London

Enrolment target

100

Start

09 Mar 2022

Estimated completion

01 Dec 2025

Oesophageal Cancer Quality of Life Bacterial Overgrowth

What is this study about?

If you've had gullet (oesophageal) cancer surgery, you might experience long-term symptoms. This study aims to understand what causes these symptoms and how they relate to the tiny germs living in your gut, also known as your microbiome. We know that these germs play a big role in our overall health, and changes in them might contribute to the issues some people face after cancer treatment.

Researchers will be looking closely at the different types of germs in your body through various samples. They're particularly interested in how the 'metabolic pathways' associated with these germs work, which basically means how these germs process things in your body. Another exciting part of this study is trying to create a new, easy breath test. This test could help doctors quickly and non-invasively detect changes in your gut germs, potentially leading to earlier diagnosis of problems.

Ultimately, by understanding these gut changes better, the study hopes to pave the way for new ways to treat any problems that arise. The goal is to improve the comfort and quality of life for people like you who have successfully overcome gullet cancer but may still be dealing with its lasting effects.

Key takeaways

Aims to understand gut health in gullet cancer survivors.
Developing a new, non-invasive breath test for gut changes.
Hopes to lead to better treatments for long-term symptoms.
Involves providing various samples and completing questionnaires.
Your participation helps improve care for others in the future.

Who may be eligible?

This study is looking for both men and women, aged 18 to 90 years old, who have had surgery for a specific type of gullet cancer called oesophageal adenocarcinoma. It's important that your cancer was treated with the aim of curing it, and that you are currently free of cancer (no signs of it returning) in the last six months or for more than five years since your surgery. Also, at least one year should have passed since your gullet surgery.

There are a few reasons why someone might not be able to join. For example, if you had a specific type of cancer at the join between your gullet and stomach (called Siewert III gastro-oesophageal junctional tumours), or if there are signs your cancer has come back. You also can't take part if you've had antibiotics in the last four weeks, as these can affect the germs in your gut, or if you are not able or willing to give your written permission to participate.

Quick self-check

Are you between 18 and 90 years old?
Have you had surgery for gullet (oesophageal) adenocarcinoma for a cure?
Has it been over a year since your gullet surgery?
Are you currently free of cancer (no recurrence in the last 6 months or more than 5 years post-surgery)?
Have you avoided antibiotics for at least the last 4 weeks?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will need to attend an outpatient clinic. Before your visit, you'll be asked not to eat or drink anything (except water) for at least 4 hours. During your visit, several samples will be collected: a breath sample, a saliva sample, a blood sample, a urine sample, and a stool (poo) sample. You will also be asked to fill out some questionnaires about your health and quality of life. The researchers will compare people who have symptoms with those who don't, to understand the differences in their gut germs and how these might be linked to their well-being. This is an observational study, meaning you won't be given any new treatments, but your health information and samples will help us learn more. The study does not specify how many visits are needed or the total length of your participation, but generally, observational studies often involve one or a few visits over a defined period.

Potential risks and benefits

Participating in this study might offer the benefit of contributing to new knowledge that could improve care for future gullet cancer survivors. While there are no direct medical benefits to you, your contribution could lead to better diagnostic tools and treatments. Risks are generally low and mainly involve the minor discomfort of blood draws, collecting samples, and the time commitment for your clinic visit. You have the right to withdraw from the study at any time, without giving a reason, and it will not affect your usual medical care.

Locations (3)

Barking, Havering and Redbridge University Hospitals NHS Trust
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
West Hertfordshire NHS Teaching Hospitals
London, United Kingdom

Common questions

What is the 'microbiome'?

The microbiome is the community of tiny living things, like bacteria, that live inside and on your body, especially in your gut. They play an important role in your health.

What is a 'breath test' and how does it work?

A breath test involves you breathing into a special bag or device. Researchers use it to look for certain chemicals in your breath that can tell them about what's happening with the germs in your gut.

Will I receive any new treatment in this study?

No, this is an 'observational' study. This means we are only gathering information and samples to understand more about your health; you won't receive any new treatments as part of this study.

What will happen to my samples?

Your samples (breath, saliva, blood, urine, stool) will be analysed by researchers to understand the types of germs present and their impact on your body.

How long will my involvement in the study last?

The study brief summary does not specify the total duration, but generally, observational studies involve one or a few visits over a defined period to collect necessary data.