A Study Measuring Markers of Airway Inflammation in Breath Samples From People With Respiratory Diseases and Healthy Volunteers.
This study is investigating a new breath test called Inflammacheck® to help detect lung cancer and other breathing conditions earlier. Lung cancer is often found late, which makes it harder to treat. Current checks mostly focus on people at high risk, meaning some cases are missed. The Inflammacheck® device measures certain chemicals in your breath that are linked to inflammation in your airways. We hope this breath test can provide a simple, quick, and affordable way for doctors in the NHS to decide if someone with long-lasting breathing problems needs more detailed investigations for suspected lung cancer. This could lead to earlier diagnosis and better treatment.
At a glance
What is this study about?
This study is looking into a new way to help doctors find lung cancer earlier, as well as understand other breathing problems. Currently, lung cancer is a serious issue in the UK because it's often found late, which makes it much harder to treat successfully. Existing screening programmes, which use special X-rays (called low-dose CT scans), are very helpful but only offered to people considered at high risk. This means that a significant number of lung cancer cases, including those in women and people who have never smoked, might be missed.
There isn't a simple, easy test that doctors can use to help decide if someone with ongoing breathing symptoms, who doesn't fit the usual high-risk criteria, needs to be checked further for lung cancer. This study is testing a device called Inflammacheck®. This device looks for certain substances in your breath that are linked to inflammation in your lungs and airways. Previous small studies have shown that Inflammacheck® might be very good at spotting lung cancer and telling it apart from other lung conditions.
The main goal of this study, called VICTORY 2, is to properly check and improve the clever computer program (AI model) that works with the Inflammacheck® device. If successful, this could mean that doctors in the NHS would have a fast, affordable, and accurate breath test to help decide who needs further investigations for suspected lung cancer. This could make a big difference by helping to diagnose lung cancer much earlier, potentially improving treatment outcomes for many people.
Key takeaways
- This study evaluates a new breath test for lung conditions.
- It aims for earlier diagnosis of lung cancer and other respiratory diseases.
- Participation involves a simple breath test and sharing medical records.
- No new medications or treatments are given during the study.
- Your involvement helps improve future diagnostic tools for lung health.
- The study is observational and low-risk.
Who may be eligible?
This study is looking for adults aged 18 or over. We are including people with a confirmed diagnosis of lung cancer, those where lung cancer is suspected but not yet confirmed, and people with other lung conditions like pneumonia, asthma, COPD, or other long-term lung diseases. We also need healthy volunteers who don't have any known breathing problems.
For those taking part, you need to be able to give your written permission to join the study and be able to perform a breath test using the device. We'll also need to look at your relevant medical information and scans to understand your health history.
You won't be able to join if you have an active serious lung infection (other than pneumonia) at the time of the breath test, or if you've had major chest surgery in the last six months. Also, if you’re currently pregnant or breastfeeding, or receiving chemotherapy or radiotherapy for lung cancer, you won't be suitable (unless your data was collected before treatment for past cases). If you have severe memory problems or difficulties understanding instructions, you also won't be able to take part.
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 18 years old or older?
- Can you provide written consent to take part?
- Are you able to perform a simple breath test?
- Do you have a lung condition, or are you generally healthy?
- Are you currently pregnant or breastfeeding? (If yes, you likely can't join)
- Have you had major chest surgery in the last 6 months? (If yes, you likely can't join)
What does participation involve?
If you take part in this study, there will be no new medical treatments or medication for you to take, as we are simply observing and measuring. Your main involvement will be performing a breath test using the Inflammacheck® device. This usually involves breathing into the device according to instructions provided by the study team. You'll also need to allow the study team to access your relevant medical records and imaging results (like X-rays or scans) to help them understand your condition and compare it with the breath test results. The study duration for each participant is usually a single visit for the breath test, though the total study itself will collect data over a longer period. There is no long-term follow-up required from you once you've completed the breath test and your data has been collected.
Potential risks and benefits
Locations (1)
- Portsmouth Hospitals University NHS TrustVerified postcodePortsmouth, United Kingdom· Recruiting
Common questions
What is Inflammacheck®?
It's a new device designed to test your breath for specific substances that could indicate inflammation or other issues in your lungs, potentially helping to detect diseases like lung cancer.
Will this study give me a diagnosis for my breathing problems?
No, this study is for research purposes to test the device. It won't give you a personal diagnosis, but your data helps us understand its potential for future use in clinics.
Do I need to change my medication if I join?
No, you don't need to change any of your current medications or treatments to take part in this study.
How long will my involvement in the study last?
Your direct involvement will usually be just for a single visit to perform the breath test and for us to collect your medical information.
What happens to my medical information?
Your medical information will be kept confidential and used only for research purposes, helping the study team to compare your breath test results with your health condition.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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