An observational study to better understand the outcomes in patients with pleural effusion due to lung cancer

Plain English summary of protocol

Background and study aims
The lungs are covered by two thin layers, called the pleura, which are vulnerable to many different diseases. If cancer spreads to the pleura, it can cause irritation and a build-up of fluid around the lung (a malignant pleural effusion). Patients affected by an effusion can experience breathlessness and lower quality of life, but there is a lot of variability between people. For example, some people produce fluid much more quickly than others and others respond better to treatment than others. At present, we can’t predict which patients will do better and which ones will do worse over time. The main aim of this study is to gather information about what happens to patients and about how these effusions evolve. Eventually, improving our knowledge in this area might help doctors better advise patients on what might happen to them and which treatments to choose.

Who can participate?
The study will focus on patients with a specific kind of lung cancer (lung adenocarcinoma) who have developed a pleural effusion. The study will be restricted to adults without any other kind of cancer, who are also able to complete the necessary follow-up visits.

What does the study involve?
If willing to participate, eligible patients will first be asked to provide us with basic details about their medical history and to have samples of blood and pleural fluid taken. We will also ask for detailed information about quality of life using special questionnaires. At the same visit, patients may also be asked to have a chest X-ray, CT scan and a thoracic ultrasound, to help us understand what is happening inside the chest. An important part of the study is analysing the pleural fluid for changes to DNA, and people will be asked to provide permission for this specifically.
Patients will then be asked to return to the study site for a further two visits to repeat the above tests, first after 3 months and then after another 3 months. After these two visits, patients will exit the study and the research team will analyse their samples and information to help answer the important study questions.

What are the possible benefits and risks of participating?
There are unlikely to be any direct benefits for patients participating in the study, however, the information obtained will hopefully allow doctors and scientists to develop new tests and treatments for people like them in the future. Some of the study tests (such as fluid drainage) carry a very small risk of harm, but this will be discussed before every procedure. In theory, the extra chest x-rays and CT scans in the study will lead to some additional radiation exposure, but this is unlikely to cause any harm and is actually similar to what often happens as part of normal patient care. The study will be approved by an ethics committee in the UK before starting, and all tests will be performed by people who are experts.

Where is the study run from?
Southmead Hospital (UK)

When is the study starting and how long is it expected to run for?
January 2024 to December 2027

Who is funding the study?
The study has been funded by the UK Medical Research Council, with additional support from Rocket Medical UK.

Who is the main contact?
1. Elisabeth North, elisabeth.north2@nbt.nhs.uk
2. Dr Rahul Bhatnagar, rahul.bhatnagar@bristol.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom

Study participating centres

Sponsor information

North Bristol NHS Trust
Hospital/treatment centre

Southmead Hospital
Bristol
BS10 5NB
England
United Kingdom

Phone	+44 (0)1179505050
Email	researchsponsor@nbt.nhs.uk
Website	http://www.nbt.nhs.uk/
"ROR"	https://ror.org/036x6gt55

Funders

Funder type

Government

Results and Publications

Editorial Notes

09/10/2024: Study's existence confirmed by UK Research and Innovation.