RecruitingPHASE2INTERVENTIONAL

Diagnostic Accuracy Study for OWL-EVO1 As a Lung Cancer EVOC® Probe (Evolution Phase 2)

This study, called "Evolution Phase 2," is looking at how well a new breath test, OWL-EVO1, can detect lung cancer. It's designed to see if the test can accurately tell the difference between people who have lung cancer and those who don't. We'll be comparing people with confirmed lung cancer to others who are clear of the disease, including some with other health conditions, to make sure the test is reliable in different situations. The aim is also to make sure the test process is straightforward for patients and doesn't take too much time for hospital staff. Participants will receive a special liquid medicine through a drip, and then give several breath samples over a few hours. The findings will help us understand how well this breath test might work in real-life hospital settings.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Owlstone Ltd

Enrolment target

350

Start

05 Oct 2023

Estimated completion

30 Apr 2025

Lung Cancer

What is this study about?

Imagine being able to breathe into a machine to find out if you have lung cancer. This study, called Evolution Phase 2a, is a step towards making that a reality. Researchers are testing a new breath test, called OWL-EVO1, to see how accurate it is at spotting lung cancer. The idea is that this special liquid medicine, OWL-EVO1, can show up in your breath if you have lung cancer, acting like a tiny signal that a machine can then pick up.

To make sure the test works well, the study needs to compare different groups of people. This includes people who have been diagnosed with lung cancer, and also people who don't have lung cancer but might have other chest problems. This way, the researchers can be confident that the test is specifically finding lung cancer and not getting confused by other health conditions. The study is also trying to find the simplest way to carry out the test so it's easy and comfortable for patients.

In an earlier stage of this research, it was shown that the OWL-EVO1 medicine is safe and can be detected in breath as planned. This next stage will help us understand how reliable and useful this breath test could be in hospitals and clinics, making diagnosis quicker and less invasive in the future.

Key takeaways

This study is testing a new breath test for lung cancer.
It aims to find out how accurate the test is and make it easy to use.
Participants will receive a special liquid medicine and give breath samples.
The study helps improve future lung cancer diagnosis.
You can choose to leave the study at any time.

Who may be eligible?

To join this study, you need to be aged between 45 and 85 years old. Your Body Mass Index (BMI) should be between 16 and under 40. You also need to have had a CT scan of your chest area within the last six months. Importantly, you must be able to understand the study information and agree to take part.

There are some reasons why you might not be able to join. For example, if you can't comfortably give breath samples, or if a doctor thinks you don't have the mental ability to understand the study. You also can't have taken part in another drug trial in the last 28 days or if that drug would still be in your system. If you're being checked for a different type of cancer (other than lung cancer) and haven't had a clear diagnosis yet, you can't join. Similarly, if you have a suspicious spot on your lung CT scan that needs ongoing monitoring rather than immediate treatment or a biopsy, you won't be suitable.

Women who are pregnant or breastfeeding, or who could become pregnant and are not using effective contraception, also cannot take part. If you've had certain types of lung surgery or special procedures in your airways (like stents), you might not be eligible. Finally, if you're suspected of having lung cancer but it's unlikely you'll get a firm diagnosis from a tissue sample before treatment begins, you also wouldn't be able to join.

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 45 and 85 years old?
Have you had a CT scan of your chest in the last 6 months?
Are you able to understand study information and agree to take part?
Are you able to comfortably give breath samples?
Are you not pregnant or breastfeeding, and using effective contraception if you could become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first be carefully checked to make sure the study is right for you. You'll receive a special liquid medicine called OWL-EVO1 through a drip into your arm. After this, you'll be asked to give several breath samples over a period of up to three hours. The total time you'll spend giving breath samples won't be more than an hour. The medical team will also gather other important health information from you, including details from your previous scans. The study aims to be as comfortable and straightforward as possible, and you'll be looked after by the medical staff throughout.

Potential risks and benefits

Taking part in this study could help doctors better understand how to diagnose lung cancer earlier and more easily in the future, which could benefit many people. For you personally, there might not be a direct medical benefit, but you will be contributing to valuable research. As with any medical procedure, there are some small risks, mainly from receiving the drip for the medicine and giving breath samples. The researchers have carefully put measures in place to keep you safe and comfortable. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (9)

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

Thomayer Hospital
Verified postcode
Prague, Czechia· Recruiting
National Koranyi Institute for Pulmonology
Verified postcode
Budapest, Hungary· Not yet recruiting
Department of Pulmonology, University of Debrecen
Verified postcode
Debrecen, Hungary· Recruiting
Royal Papworth Hospital NHS Foundation Trust
Verified postcode
Cambridge, United Kingdom· Recruiting
Wythenshawe Hospital
Verified postcode
Manchester, United Kingdom· Recruiting
Glenfield Hospital
Verified postcode
Leicester, United Kingdom· Recruiting
Barts Health NHS Trust
Verified postcode
London, United Kingdom· Not yet recruiting
Imperial Centre for Translational and Experimental Medicine, Imperial College
Verified postcode
London, United Kingdom· Recruiting
Quadram Institute
Verified postcode
Norwich, United Kingdom· Recruiting

Common questions

What is a 'breath biopsy'?

A breath biopsy is a new way to test for diseases by looking at tiny chemicals in your breath. This study is testing if it can find signals of lung cancer.

Will I have to stay in the hospital?

You will need to visit a research site for the test, but you won't typically need to stay overnight. The sampling part of the test lasts a few hours.

Is the OWL-EVO1 medicine safe?

Yes, previous studies have shown that the OWL-EVO1 medicine is safe and well-tolerated. It's designed to be easily detectable in your breath.

What is a 'contrast group'?

A 'contrast group' includes people who don't have lung cancer. Comparing them to people with lung cancer helps the researchers check if the test is accurate.

Will I get my test results from this study?

The main purpose of the study is to evaluate the test, not to give individual diagnoses. Your doctor will discuss any relevant medical findings with you.

How to find out more

Liz Thompson

EDLC@owlstone.co.uk 01223 428200 Official trial record

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