RecruitingOBSERVATIONAL

Rapid Absorbance-based Detection of Inner Cheek Cell Abnormalities Using Light Spectroscopy for Risk Evaluation of Lung Cancer to Enable Critical Decision Support in Targeted Patient Populations

This study is looking at a new way to find lung cancer early using a simple cheek swab test called AIR-DS. The test works by checking for very small changes in cells from the inside of your cheek, which could be early signs of lung cancer. It uses a special light to analyse the swab and doesn't involve any needles or complicated procedures. The AIR-DS test could make it much easier to detect lung cancer at an earlier stage, when it's often more treatable. This study needs about 450 people who might have lung cancer to take part. They will provide a cheek swab and some basic health information during one visit. The aim is to see how accurately AIR-DS can identify people with lung cancer.

At a glance

Status

Recruiting

Sponsor

Sierra Medical Ltd.

Enrolment target

450

Start

02 Jan 2025

Estimated completion

15 Aug 2026

Lung Cancer

What is this study about?

Researchers are developing an innovative new test called AIR-DS that aims to detect lung cancer early using a simple cheek swab. This test is designed to be quick, easy, and non-invasive, meaning it doesn't involve surgery or uncomfortable procedures. The idea is to catch lung cancer at its earliest stages, when treatment is often most effective and chances of a good outcome are higher.

How does it work? The AIR-DS test looks for very tiny, early changes in the cells on the inside of your cheek. These changes, though small, can sometimes be linked to the presence of lung cancer. A small swab is gently rubbed inside your cheek to collect some cells, similar to a cotton bud. This sample is then analysed using a special infrared light, which can 'see' these subtle biochemical changes without causing any harm.

This study, called RADICAL REACT, is crucial to make sure the AIR-DS test works well in a real healthcare setting. Around 450 people who are suspected of having lung cancer will be invited to take part. Each participant will provide a cheek swab and some basic information about their health during a single visit to the clinic. By analysing these samples, the researchers hope to confirm if AIR-DS can accurately identify people who have lung cancer, paving the way for this promising new diagnostic tool.

Key takeaways

Researchers are testing a new cheek swab test (AIR-DS) to detect lung cancer early.
The test is simple, quick, and non-invasive, using light to analyse cells.
It aims to find lung cancer at its most treatable stages, improving outcomes.
Participation involves one clinic visit for a cheek swab and health information.
This study could lead to a less invasive and more cost-effective way to find lung cancer.
Taking part helps advance medical research for future patients.

Who may be eligible?

To join this study, you need to be at least 18 years old and be able to understand and sign a consent form. You must also be able to provide a cheek swab sample. Importantly, you should be experiencing symptoms that suggest you might have lung cancer, or you already be undergoing tests to check for it. You cannot have started treatment for lung cancer yet.

There are certain reasons why you might not be able to join. For example, if you are pregnant, or if you've recently been diagnosed with another type of cancer within the last five years (unless it was a very specific, less serious skin or prostate cancer, or a cervical cell change). You also can't take part if you have certain mouth conditions like bleeding gums, or if you're taking blood-thinning medicines. Some long-term health conditions that are not well-controlled, like high blood pressure or asthma, or specific conditions like tuberculosis, could also mean you're not eligible.

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 a simple cheek swab sample?
Are you currently being checked for lung cancer or have symptoms of it?
Have you started any treatment for lung cancer yet? (You cannot have started treatment.)
Are you pregnant? (You cannot be pregnant to join.)
Do you have certain specific mouth problems or are you on blood-thinning medication? (These might stop you from joining.)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will only involve one visit to the clinic. During this visit, a healthcare professional will gently take a swab from the inside of your cheek. This is a very simple and quick procedure, similar to using a cotton bud. You will also be asked some basic questions about your health and medical history. There will be no medication to take as part of the study, and no further visits or follow-ups are required for the study itself after this single clinic visit. This study does not provide treatment; it is solely focused on testing the new diagnostic method.

Potential risks and benefits

The main benefit of this study is helping to develop a potentially revolutionary test that could find lung cancer earlier and more simply for many others in the future. For you personally, there are no direct health benefits from taking part, as this test is for research and won't influence your current care plan. The risks are very low; taking a cheek swab is generally harmless, but some people might feel a brief, very mild discomfort. There are no known risks from the infrared light analysis. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

Northumbria Healthcare NHS Foundation Trust
Verified postcode
North Shields, United Kingdom· Recruiting
Queen Alexandra Hospital
Verified postcode
Portsmouth, United Kingdom· Recruiting

Common questions

What is a cheek swab?

A cheek swab is a simple procedure where a healthcare professional uses a soft stick, like a long cotton bud, to gently rub the inside of your cheek to collect some cells. It's quick and usually painless.

Will this test tell me if I have lung cancer?

No, this study is testing the new AIR-DS method, so it won't give you results for your personal diagnosis. Your doctors will continue to use standard medical tests to tell you about your health.

Is the AIR-DS test safe?

Yes, the AIR-DS test involves a simple cheek swab and uses non-damaging infrared light. There are no known safety concerns or side effects from the test itself.

How long will my participation last?

Your participation will only involve one single visit to the clinic for the cheek swab and medical history questions. There are no follow-up visits specifically for the study.

Do I have to stop my current medicines to join?

You should continue all your current medicines unless your doctor or the study team advises otherwise. However, if you are taking blood-thinning medication, you may not be able to join the study.

How to find out more

Kim Ibsen

kim@sierramedical.co.uk +447930089467 Official trial record

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