ASSESS-meso: a long-term study looking at people with mesothelioma (cancer of the outer lining of the lung) that will gather information on symptoms, disease processes and factors that affect survival

Plain English summary of protocol

Background and study aims
Mesothelioma is an aggressive cancer that usually affects the outside lining of the lung, but can also affect the lining of the heart or abdomen. It usually arises as a result of previous exposure to asbestos, often more than 40 years previously. Rates of mesothelioma diagnosis have increased steadily over the past decade, in the UK and worldwide, and are predicted to continue rising over the next 5-10 years. Unfortunately the average life-expectancy of a person diagnosed with mesothelioma is less than a year. This is because it is very difficult to treat, with only one chemotherapy treatment that has been shown to be effective. On average, this chemotherapy allows people to live approximately 3 months longer, although some people respond really well and go on to live for many months or even years. Unfortunately at the moment, we can’t predict which people will be the ones to respond well to chemotherapy. Lots of new treatments are being developed for mesothelioma. There is more to learn about mesothelioma, specifically whether there are any patient characteristics, factors relating to the tumour or blood tests that predict which patients might live longer and reponses to chemotherapy. This may help make better treatment decisions for individual patients. This information is will be gathered by setting up a database (cohort) of patients with mesothelioma diagnosed at our hospital, and at other hospitals in the UK. The cohort will also be used as a resource for identifying patients who are suitable to participate in clinical trials. The aim of the study is to collect information about mesothelioma and the people who develop it, their symptoms, and how things change over time, whilst also screening participants for participation in clinical trials.

Who can participate?
Adults aged 18 and older who have mesothelioma

What does the study involve?
Participants in the study are followed up in accordance with usual clinical care (aiming to have appointments every 3 months or so). At each visit routine clinical data is collected, such as what treatments participants have had since their last appointment and whether they are still draining fluid from their chest. Imaging, such as chest x-rays and ultrasound scans will be undertaken at every appointment. CT scans are done every 6 months. Blood tests are taken at every study appointment, and if participants have fluid in their chest, a sample of this may be taken and stored. Participants are also asked to complete a symptom score and a quality of life questionnaire at each appointment. Participants are followed up from the day they receive their diagnosis for their whole life, or until they withdraw from the study. If participants find it too tiring or difficult to come to appointments in hospital, they are offered a telephone follow up.

What are the possible benefits and risks of participating?
There is no direct benefit for people taking part in the study. The information they provide will help doctors learn more about mesothelioma and potentially help future patients diagnosed with this disease. In future we intend to use the study to screen people to see if they are eligible to participate in clinical trials. As this study does not include an intervention, there are few risks to taking part. The additional time taken to complete the study assessments and up to 4 extra blood tests per year are potential disadvantages. Participants may be asked to undergo up to 2 extra CT scans and up to 4 extra chest x-rays per year, which involves exposure to radiation. However, this is only a small amount, and is unlikely to cause any significant health problems.

Where is the study run from?
1. Southmead Hospital (UK)
2. Churchill Hospital (UK)
3. Musgrove Park Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2016 to December 2028

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Anna Bibby (Scientific)

Contact information

Dr Anna Bibby
Scientific

Academic Respiratory Unit
Bristol Medical School
2nd Floor L&R Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

ORCID ID	0000-0001-7386-7754
Phone	+44 (0)117 4148049
Email	anna.bibby@bristol.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England
• Scotland

Study participating centres

Results and Publications

Study outputs

Additional files

ISRCTN61861764_PIS_v2.3.docx

Uploaded 01/04/2019

ISRCTN61861764_Protocol_v1.9_14Dec2023.pdf

Protocol file

Editorial Notes

07/02/2025: The following study participating centres were added: Basildon Hospital, Broomfield Hospital, Southend Hospital and Freeman Hospital.
24/01/2025: The following changes were made:
1. Protocol file (not peer reviewed) version 1.9 uploaded.
2. IRAS number added.
3. The following study participating centres were added: Greater Glasgow and Clyde, Sherwood Forest Hospitals NHS Foundation Trust, Velindre Cancer Centre, South Tyneside NHS Foundation Trust, Clatterbridge Cancer Centre, Gloucestershire Hospitals NHS Foundation Trust, Sheffield Teaching Hospitals, NHS Highland and University Hospitals of Morecambe Bay NHS Foundation Trust.
08/01/2024: Publication reference added.
11/11/2022: Publication reference added.
09/07/2020: The trial contact details have been made publicly visible.
01/04/2019: The participant information sheet has been uploaded.
27/03/2019: The condition has been changed from "Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Cancer/ Malignant neoplasms of respiratory and intrathoracic organs" to "Mesothelioma (cancer of the outer lining of the lung)" following a request from the NIHR.
02/02/2018: Internal review.