CompletedObservational

STRATIFY: Staging by thoracoscopy in potentially radically treatable non-small cell lung cancer associated with minimal pleural effusion

Early-stage non-small cell lung cancer is often treated with intensive options like surgery or radiotherapy to try and cure it. However, if cancer cells have already spread to the lining of the lung (the pleura), these harsh treatments may not work and can cause difficult side effects. Sometimes, patients develop a tiny rim of fluid around the lung that is too small to test easily with a standard needle. The STRATIFY study looks at whether using a small camera (a thoracoscopy) inside the chest can help doctors spot early cancer spread. During the test, doctors examine the lung lining and take tiny tissue samples. Knowing the exact stage of the cancer helps your medical team recommend the best treatment for you, while avoiding major treatments that will not help. The study is running in several NHS hospitals across the UK.

At a glance

Status

Completed

Sponsor

NHS Greater Glasgow and Clyde

Enrolment target

Start

01 Dec 2019

Estimated completion

31 Oct 2023

Lung cancer

What is this study about?

When doctors find early-stage non-small cell lung cancer, they often aim to cure it using major surgery or combined radiotherapy and chemotherapy. In some people, a small layer of fluid gathers in the space between the lung and the chest wall. Even when this fluid buildup is tiny, it can sometimes be a sign that cancer cells have begun to reach the thin membrane covering the lung, called the pleura.

Standard tests cannot always tell if this fluid contains cancer cells because there is often too little fluid to remove safely with an ordinary needle. If the cancer has reached the lung lining, putting a patient through major surgery or intensive chemoradiotherapy will not cure the disease and may cause unnecessary illness and distress. Doctors need a better way to look closely at the lung lining before deciding on a treatment plan.

The STRATIFY study is testing whether a camera procedure called a thoracoscopy can provide clear answers. By looking directly inside the chest and taking small tissue samples, doctors hope to stage the cancer more accurately. This ensures that each patient receives the most suitable care and avoids toxic, demanding treatments that cannot help them.

Key takeaways

The STRATIFY study tests whether a camera check inside the chest helps accurately stage early lung cancer.
It is designed for people who have a small amount of fluid around their lung that cannot easily be tested with a standard needle.
The procedure is done either with local numbing medicine (awake) or through keyhole surgery (asleep).
Accurate results help patients avoid harsh treatments that may not work and guide doctors toward better options.
No extra clinic visits are required after the procedure, as researchers follow your progress through your medical records.

Who may be eligible?

You may be able to join the STRATIFY trial if you are aged 16 or over and have suspected or confirmed early-stage non-small cell lung cancer (stage I to IIIA). You must also have a small amount of fluid around one of your lungs that is either too small to sample with a simple needle or did not show cancer cells in previous tests.

To take part, you should be generally well enough to manage everyday tasks and fit enough for potential cancer treatments. Your care team will also make sure it is safe for you to have either a numbing procedure or keyhole surgery.

You cannot join the study if tests have already confirmed that your cancer has spread to other parts of your body or across the lung lining. People who have certain lung conditions, severe bleeding disorders, or other medical issues that make chest procedures unsafe will also be unable 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.

I am aged 16 or older.
I have suspected or confirmed stage I to IIIA non-small cell lung cancer.
I have a small amount of fluid around one lung (pleural effusion).
My fluid was either too small to test safely or tested negative for cancer cells.
I am well enough to carry out day-to-day activities and consider cancer treatment.
I do not have known cancer spread to other organs or confirmed spread to the lung lining.

Answer every question to see your result.

What does participation involve?

If you take part, you will first have a chest ultrasound scan and a routine health check to record your blood pressure, temperature, pulse, and current medicines. You will then have a thoracoscopy. This camera test is performed in one of two ways: either using local anaesthetic to numb the area while you are awake (LAT), or as keyhole surgery in an operating theatre while you are asleep under general anaesthetic (VATS). You will have a chest X-ray before and after the procedure.

During the test, the doctor will take small tissue samples and remove fluid. You may be invited to donate a sample of fluid and an extra blood sample for future lung cancer research, but this is optional. Depending on which procedure you have, you may go home the same day or stay in hospital for up to three days. After leaving hospital, you will not need to attend extra clinic appointments for the trial. The research team will simply review your hospital records over the next six months to see how you are getting on.

Potential risks and benefits

The main benefit of taking part is receiving treatment based on a clearer, more accurate assessment of your cancer. If doctors discover the cancer has spread to the lung lining, you can avoid aggressive, toxic treatments that would not cure the disease. However, the camera procedure can cause temporary discomfort, bruising, or mild pain, though you will receive painkillers to keep you comfortable. Other risks, such as bleeding or chest infection, are uncommon. Taking part is completely voluntary. You are free to say no or leave the study at any point, and your decision will not affect the standard of care you receive from the NHS.

Locations (8)

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

NHS Greater Glasgow & Clyde, Queen Elizabeth Iniversity Hospital
Unverified
Glasgow, Scotland
University Hospital of South Manchester NHS Foundation Trust
Unverified
Manchester, England
Oxford University Hospitals NHS Foundation Trust
Unverified
OXFORD, England
North Bristol NHS Trust, Southmead Hospital
Unverified
Bristol, England
Guy's and St Thomas NHS Foundation Trust
Unverified
London, England
Salford Royal NHS Foundation Trust
Unverified
Salford, England
University Hospitals Plymouth NHS Trust
Unverified
Plymouth, England
Kingsmill Hospital
Unverified
Nottingham, England

Common questions

What is the difference between LAT and VATS?

LAT uses local anaesthetic to numb your chest so you stay awake without feeling pain. VATS is a type of keyhole surgery done in an operating theatre under general anaesthetic, meaning you are asleep throughout.

Will taking part cure my cancer?

No, the camera test is a diagnostic test rather than a cure. Its purpose is to show the exact stage of your cancer so your doctors can pick the most effective treatment for you.

Do I have to stay overnight in the hospital?

Some patients having a local anaesthetic procedure can go home the same day. Those having keyhole surgery under general anaesthetic may need to stay in hospital for up to three days.

Do I have to give extra blood or fluid for research?

No, donating extra samples for future cancer research is completely optional. You can still take part in the main study even if you prefer not to donate these samples.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without giving a reason. Your standard NHS care and your relationship with your medical team will remain exactly the same.

How to find out more

Kevin Blyth

kevin.blyth@glasgow.ac.uk +44 (0)141 330 3180 Official trial record

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