Plain English Summary
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)
Trial website
Contact information
Type
Scientific
Primary contact
Dr Anna Bibby
ORCID ID
http://orcid.org/0000-0001-7386-7754
Contact details
Academic Respiratory Unit
Bristol Medical School
2nd Floor L&R Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
+44 (0)117 4148049
anna.bibby@bristol.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
33514
Study information
Scientific title
A prospective observational cohort study collecting data on demographics, symptoms and biomarkers in people with mesothelioma that will provide a resource for future trials
Acronym
ASSESS-meso
Study hypothesis
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.
Ethics approval
South West - Central Bristol Research Ethics Committee, 14/03/2017, ref: 17/SW/0019
Study design
Observational; Design type: Cohort study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files
Condition
Mesothelioma (cancer of the outer lining of the lung)
Intervention
This is an observational study, with no additional intervention above usual clinical care. Participants are followed up from the point of diagnosis until death or withdrawal from the study. Data is collected during routine clinical appointments, every three months as a minimum. There is the option to switch to telephone follow up if participants are no longer undergoing hospital follow up.
Patients who agree to join the cohort provide clinical information at the point of diagnosis, alongside samples of blood and pleural fluid for analysis. Additional blood and pleural fluid samples are kept, and stored anonymously, for further testing in the future. Participants then continue to be followed up in clinic, approximately every 3 months. At every clinic appointment, participants provide more information, for example about the severity of their current symptoms, which will be collected and added to the database. If possible, further samples of pleural fluid and blood are also be taken at these appointments. Participants continue to provide information for the cohort at every pleural clinic appointment for the rest of their life.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Survival is measured as time from diagnosis to death (or censored at the point of withdrawal from the study) at every study visit.
Secondary outcome measures
1. Disease progression, assessed on CT scans using modified RECIST criteria at baseline and every 6 months
2. Change in serum mesothelin from baseline, assessed on blood tests taken at baseline and every 3 months
3. Patient reported symptom scores for breathlessness, chest pain and sweats, measured using visual analogue scales at baseline and every 3 months.
4. Patient reported quality of life, assessed using the EQ-5D-5L questionnaire, at baseline and every 3 months.
5. Pleurodesis rates assessed using pleural catheter drainage diaries, chest x-ray and thoracic ultrasound every 3 months. Pleurodesis is defined as "less than 50ml of pleural fluid drained on 3 or more successive drainages, with no evidence of residual fluid on chest x-ray or ultrasound".
6. Health services utilisation, assessed from patient history and hospital records every 3 months.
In addition data will be collected on confounding factors including:
1. Patient characteristics e.g. age, sex, presence of comorbidities, performance status - collected at baseline from patient history & medical records
2. Tumour variables e.g. histological type, disease site - collected at baseline from medical records
3. Treatment factors e.g. chemotherapy, radiotherapy, participation in clinical trials - collected at baseline and every 3 months based on patient history 7 medical records
Overall trial start date
01/09/2016
Overall trial end date
31/12/2028
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histological, cytological or clinico-pathological diagnosis of mesothelioma, confirmed at MDT
2. Willing and able to comply with study follow up assessments (including at least 1 appointment at a study recruiting centre if identified at a PIC)
3. Has capacity, as defined by the 2005 Mental Capacity Act
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 700; UK Sample Size: 700
Participant exclusion criteria
1. Age < 18 years old
2. Unable to give written informed consent
3. Declines ongoing hospital follow up
Recruitment start date
01/07/2017
Recruitment end date
30/06/2027
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southmead Hospital
North Bristol NHS Trust
Westbury on Trym
Bristol
BS10 5NB
United Kingdom
Trial participating centre
Churchill Hospital
Oxford University Hospitals NHS Foundation Trust
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Trial participating centre
Musgrove Park Hospital
Taunton & Somerset NHS Foundation Trust
Taunton
TA1 5DA
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Publication in a peer reviewed journal is planned for 2028. In addition results will be disseminated to the scientific community via presentation at conferences. Patients, participants and carers will be kept informed via presentation at patient conferences, and newletters such as the British Lung Foundation and Mesothelioma UK. Publication of the study protocol in a peer-reviewed journal is planned in the next year.
IPD sharing statement:
The datasets generated during the current study will be available upon request from Dr Anna Bibby (anna.bibby@bristol.ac.uk) from December 2028 for 10 years. Pseudonymised patient-level data will be provided as Excel or STATA files for analysis in ethically approved research studies. Individual participant consent has been obtained for this type of data sharing.
Intention to publish date
01/06/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN61861764_PIS_v2.3.docx Uploaded 01/04/2019