Condition category
Cancer
Date applied
08/01/2018
Date assigned
24/01/2018
Last edited
02/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

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

Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Cancer/ Malignant neoplasms of respiratory and intrathoracic organs

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

Sponsor information

Organisation

North Bristol NHS Trust Research & Innovation Department

Sponsor details

3rd Floor
Learning & Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/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

Editorial Notes

02/02/2018: Internal review.