A study to find out more about mesothelioma (Meso-ORIGINS)

Cancer type:

Mesothelioma

Status:

Open

Phase:

Other

This study is to learn more about mesothelioma and how it develops after exposure to asbestos Open a glossary item .

It is open to people who have:

been exposed to asbestos
had a sample of tissue (biopsy ) of the lining of the lung (pleura) in the last year that showed signs of pleural inflammation
fluid on the lung (pleural effusion )
had a scan or x-ray showing an abnormal growth on the lining of the lung
a non cancerous (benign ) abnormality on the lining of their lung

More about this trial

Mesothelioma is a cancer that affects the lining of the lungs (pleura). Exposure to asbestos can cause inflammation Open a glossary item of the pleura. This can be non cancerous (benign) or it might develop into mesothelioma.

In this study researchers want people whose inflammation is non cancerous to take part. They want to collect past tissue samples that led to the diagnosis of pleural inflammation. They will take another sample if it develops into mesothelioma. They will also take blood samples and look at their scans. The team will ask some people to breath into a bag to collect a sample of their breath.

The study team are also taking samples of pleural tissue from people who might have a diagnosis of mesothelioma. The team will also take blood samples and look at their scans.

The aim of this study is to find out how benign inflammation develops into mesothelioma in people after exposure to asbestos.

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

There are 2 groups in this study.

You can join the study if you are at least 16 years old.

Group A
You may be able to join group A if all of the following apply. You:

have had exposure to asbestos in the past or you have had a scan that shows abnormalities of the lining of the lungs (pleura) such as pleural plaques
had a sample of tissue (biopsy) taken from the lining of the lung within the past year that shows inflammation of the lining

Group B
You may be able to join group B if all of the following apply. You:

have had exposure to asbestos in the past or you have had a scan that shows abnormalities of the lining of the lungs (pleura) such as pleural plaques
might have mesothelioma because you have fluid on one side of the lung (pleural effusion) or you have a growth on the lining of the lung
are fit enough to have a thoracoscopy

Who can’t take part

Group A
You cannot join group A of this study if any of these apply. You:

are confirmed to have mesothelioma
have an infection in the lining of the lung. This includes tuberculosis (TB).
have a small area of inflammation of lung lining that is caused by an infection
any other disease that affects the lining of the lung such as rheumatoid arthritis pleurisy

Group B
You cannot join group B of this study if you have or had a tube put between the ribs to drain fluid off the lung. This is an intercostal chest drain.

You cannot join either group A or group B if you have had the lining of the lungs sealed to stop fluid collecting (pleurodesis) Open a glossary item .

Trial design

This an observation study with some sample collection. There are 2 groups. The team need 500 people to join group A and 39 people to join group B.

Group A
You give a blood sample and a breath sample. The team will take a sample of the fluid around your lung if you have a drain in place to remove the fluid. The team will ask to collect blood samples every 6 months for 2 years.

Your doctor might ask for some tests and scans if they think there are changes on your CT scan. Should this happen during the study the team will ask for the results of these tests. They will also ask for a piece of the tissue sample (biopsy) if your doctor has taken a biopsy.

After a year and half in the study, if the CT scan has shown no changes the study team might ask for another scan and a biopsy. You don’t have to agree to this if you don’t want to.

MRI sub study for group A
The team will ask for an MRI scan in the first 3 weeks when you join the study. You don’t have to agree to have it if you don’t want to.

You may not be able to take part in this sub study if you have any metal in your body such as an implant or pacemaker. They will go through a checklist before you have the MRI to make sure you are able to have it.

The study team will use the MRI scan to look for changes in the chest that might help doctors identify people who might be at risk of developing mesothelioma.

Group B
As part of your routine care you have a thoracoscopy. When you have the thoracoscopy the team ask to take additional samples of tissue (biopsy) of the lining of the lung and a sample of the fluid removed. They use these samples to find out more about why and how mesothelioma develops.

Hospital visits

Everyone sees the doctor before joining the study. This is to talk about the study, see if you are able to join and have the following tests:

a physical examination
blood test
CT scan

Group A
You see the doctor every 6 months for 2 years. Where possible the study appointments will be at the same time as your routine care appointments.

You have a CT scan every 6 months.

Group B
You have no extra hospital visits as part of the study. After you see the doctor to talk about the results of the thoracoscopy the study team will take a record of the results and your diagnosis.