Protocol for a prospective observational cohort study collecting data on demographics, symptoms and biomarkers in people with mesothelioma (ASSESS-meso)

Abstract

IntroductionMesothelioma is a heterogeneous disease that can be challenging to monitor and prognosticate. ASSESS-meso is a multicentre, prospective, longitudinal observational cohort study of patients with mesothelioma. The primary aim is to describe different clinical phenotypes and investigate predictive and prognostic factors, including biomarkers from blood and pleural fluid. The secondary aim is to provide a resource for future trials and substudies.Methods and analysisWe aim to recruit 700 patients with a histological, cytological or clinicopathological diagnosis of mesothelioma, at any anatomical site (pleural, peritoneal, pericardial, etc). Longitudinal data will be collected, including clinical information, radiological investigations, blood tests and patient-reported outcome measures for breathlessness, chest pain and sweats. Preplanned analyses will use Cox proportional hazards method to evaluate factors associated with survival, linear and logistic regression models to investigate associations with symptoms, and analysis of variance modelling to explore changes in symptoms over time.Ethics and disseminationEthical approval has been granted by the Research Ethics Committee South West—Central Bristol (17-SW-0019) and Health Research Authority (IRAS ID 220360). A study steering committee has been established and results will be published OpenAccess in peer-reviewed journals.Trial registration numberISRCTN: 61861764.

Reflecting real-world patients with mesothelioma in research: an interim report of baseline characteristics from the ASSESS-meso cohort

“…ASSESS-meso is an ongoing, multicentre, prospective, longitudinal, observational cohort study of people with mesothelioma, the protocol of which has been published elsewhere [ 36 ]. Eligible participants were recruited at 14 hospitals across the UK (12 in England, one in Scotland, one in Wales), including a mix of secondary and tertiary care providers.…”

“…ASSESS-meso was designed to address this research gap [ 36 ]. In this paper, we report the pre-specified interim analysis of ASSESS-meso, undertaken when recruitment reached 25% of target.…”

The Trial within Cohorts (TwiCs) study design in oncology: experience and methodological reflections

“…The investigational product is called OK-432 (“dead” bacteria) which is used to stimulate immune cells to attack the mesothelioma. The trial was initiated within the ASSESS-meso cohort [ 26 ] Completed 45 patients RECTAL BOOST [ 27 – 29 ] Randomized controlled trial for pre-operative dose-escalation BOOST in locally advanced rectal cancer. The trial was originally initiated within the prospective data collection initiative on colorectal cancer (PICNIC) cohort, which has been renamed to PLCRC [ 9 , 10 ] Completed 120 patients HONEY [ 30 ] Clinical trial of assessing the effect of hyperbaric oxygen therapy in breast cancer patients with late radiation toxicity.…”