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ASSESS-meso clinical trial

ASSESS is an observational study collecting data on demographics, symptoms and biomarkers in people with mesothelioma, to provide a resource for future trials.

There is a lack of longitudinal data in mesothelioma. At present, little is known about symptom progression in mesothelioma, and whether symptoms relate to clinical outcomes.

Another important area for mesothelioma research is prognostic biomarkers. An accurate biomarker could be used in clinical practice to assess individual patients’ responses to treatment and overall disease stability. In research, biomarkers are helpful surrogates for measuring the efficacy of novel treatments.

A final issue in mesothelioma research is recruitment into trials. Historically trials have struggled to recruit to target and some have been closed down due to poor enrolment.

ASSESS-meso aims to address these issues. By establishing a cohort of patients, who are followed up from diagnosis until death, with regular recording of patient-reported outcome measures, quality of life questionnaires and collection of biological samples, we will be able to describe the natural history of the disease, document changes in symptomatology, and explore factors associated with survival. Furthermore, the cohort will provide a resource from which

TwiCs can be undertaken, with potential benefits for research efficiency and equity. (TwiC is trial design which uses existing cohorts of patients to recruit to trials).

Aims & objectives
The aims of ASSESS-meso are:

• To collect longitudinal data on patients with mesothelioma to provide information on the natural history of the disease and allow comparison of outcomes

• To create a bank of biological samples for the investigation of novel biomarkers and exploration of biochemical factors that may influence outcome

• To provide a resource from which to conduct trials within the cohort.

Inclusion criteria
To be eligible to participate in the cohort, patients must meet all of the following criteria:

• Histological, cytological or clinicopathological diagnosis of MPM, confirmed at MDT

• 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)

• Has capacity, as defined by the 2005 Mental Capacity Act

Exclusion criteria
To be eligible for the cohort, none of the following criteria should apply:

• Age <18 years old

• Unable to give written informed consent

• Declines ongoing hospital follow up

Recruitment target
We are aiming to recruit 700 participants over a 10-year period.

Study schedule
Patients will be approached in clinic and those who enrol will undergo baseline assessment at that time. Subsequent study assessments will be undertaken at participants’routine clinic appointments, based on a flexible schedule, with data collection every three months as a minimum.

Consent for TwiCs
Patients enrolled into ASSESS-meso can choose to be considered for trials through the TwiC design, if they wish.

For more information about ASSESS-meso and/or TwiCs please email
nbn-tr.tilttrial@nhs.net.