Results of the Meso-ORIGINS feasibility study regarding collection of matched benign-mesothelioma tissue pairs by longitudinal surveillance
Objectives To assess key elements of the design for Meso-ORIGINS (Mesothelioma Observational study of RIsk prediction and Generation of paired benign-meso tissue samples, Including a Nested MRI Substudy), an ambitious, UK-wide, prospective study that will collect ≥63 matched benign-mesothelioma tiss...
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BMJ Publishing Group
2023-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/8/e067780.full |
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| author | Selina Tsim Kevin G Blyth Najib M Rahman Nick A Maskell Matthew Evison Rachel Mercer Katie Ferguson Jenny King Matthew Neilson Kelly Marshall Hugh Welch |
| author_facet | Selina Tsim Kevin G Blyth Najib M Rahman Nick A Maskell Matthew Evison Rachel Mercer Katie Ferguson Jenny King Matthew Neilson Kelly Marshall Hugh Welch |
| author_sort | Selina Tsim |
| collection | DOAJ |
| description | Objectives To assess key elements of the design for Meso-ORIGINS (Mesothelioma Observational study of RIsk prediction and Generation of paired benign-meso tissue samples, Including a Nested MRI Substudy), an ambitious, UK-wide, prospective study that will collect ≥63 matched benign-mesothelioma tissue pairs through longitudinal surveillance and repeat biopsy of patients with asbestos-associated pleural inflammation (AAPI).Design A multicentre, mixed-methods feasibility study, comprising a prospective observational element, evaluating recruitment feasibility, technical feasibility of repeat local anaesthetic thoracoscopy (LAT) and patient acceptability, and a retrospective cohort study focused on AAPI-mesothelioma evolution rate, informing sample size.Setting 4 UK pleural disease centres (February 2019–January 2020).Participants Patients with AAPI (history or typical imaging plus appropriate pleural histology) were eligible for both elements. In August 2019, eligibility for the prospective element was broadened, including addition of radiological AAPI for technical feasibility and patient acceptability endpoints only. Retrospective cases required ≥2 years follow-up.Outcome measures A prospective recruitment target was set a priori at 27 histological AAPI cases (or 14 in any 6 months). Technical feasibility and patient acceptability were determined at 6-month follow-up by thoracic ultrasound surrogates and questionnaires, respectively. Retrospective malignant pleural mesothelioma evolution rate was defined by proportion (95% CI). Baseline predictors of evolution were identified using logistic regression.Results 296 patients with AAPI (39 prospective, 257 retrospective) were recruited/selected. 21/39 prospective recruits were histologically diagnosed (target n=27). Repeat LAT was technically feasible and acceptable in 13/28 (46%) and 24/36 (67%) cases with complete follow-up data. Mesothelioma evolution was confirmed histologically in 36/257 retrospective cases (14% (95% CI 10.3% to 18.8%)) and associated with malignant CT features (OR 4.78 (95% CI 2.36 to 9.86)) and age (OR 1.06 (95% CI 1.02 to 1.12)).Conclusions Our initial eligibility criteria were too narrow. Meso-ORIGINS will recruit a broader cohort, including prevalent cases, any biopsy type and patients with malignant CT features. A range of rebiopsy techniques will be allowed, accounting for technical and patient factors. The sample size has been reduced to 500.Trial registration number ISRCTN12840870. |
| format | Article |
| id | doaj-art-c6450df40a1e436f9b04b413f5947036 |
| institution | Kabale University |
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| language | English |
| publishDate | 2023-08-01 |
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| spelling | doaj-art-c6450df40a1e436f9b04b413f59470362024-11-14T16:20:09ZengBMJ Publishing GroupBMJ Open2044-60552023-08-0113810.1136/bmjopen-2022-067780Results of the Meso-ORIGINS feasibility study regarding collection of matched benign-mesothelioma tissue pairs by longitudinal surveillanceSelina Tsim0Kevin G Blyth1Najib M Rahman2Nick A Maskell3Matthew Evison4Rachel Mercer5Katie Ferguson6Jenny King7Matthew Neilson8Kelly Marshall9Hugh Welch10School of Cancer Sciences, University of Glasgow, Glasgow, UKSchool of Cancer Sciences, University of Glasgow, Glasgow, UKOxford Centre for Respiratory Medicine, Churchill Hospital, Oxford, UK1 Academic Respiratory Unit, University of Bristol, Bristol, UK1 Manchester Thoracic Oncology Centre, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UKOxford Centre for Respiratory Medicine, Churchill Hospital, Oxford, UKGlasgow Pleural Disease Unit, Queen Elizabeth University Hospital Campus, Glasgow, UKDivision of Infection, Immunity and Respiratory Medicine, The University of Manchester Faculty of Biology Medicine and Health, Manchester, UK3 Department of Integrated Health Services, World Health Organization, Geneva, SwitzerlandDepartment of Respiratory Medicine, University Hospital of South Manchester, Manchester, UKAcademic Respiratory Unit, University of Bristol, Bristol, UKObjectives To assess key elements of the design for Meso-ORIGINS (Mesothelioma Observational study of RIsk prediction and Generation of paired benign-meso tissue samples, Including a Nested MRI Substudy), an ambitious, UK-wide, prospective study that will collect ≥63 matched benign-mesothelioma tissue pairs through longitudinal surveillance and repeat biopsy of patients with asbestos-associated pleural inflammation (AAPI).Design A multicentre, mixed-methods feasibility study, comprising a prospective observational element, evaluating recruitment feasibility, technical feasibility of repeat local anaesthetic thoracoscopy (LAT) and patient acceptability, and a retrospective cohort study focused on AAPI-mesothelioma evolution rate, informing sample size.Setting 4 UK pleural disease centres (February 2019–January 2020).Participants Patients with AAPI (history or typical imaging plus appropriate pleural histology) were eligible for both elements. In August 2019, eligibility for the prospective element was broadened, including addition of radiological AAPI for technical feasibility and patient acceptability endpoints only. Retrospective cases required ≥2 years follow-up.Outcome measures A prospective recruitment target was set a priori at 27 histological AAPI cases (or 14 in any 6 months). Technical feasibility and patient acceptability were determined at 6-month follow-up by thoracic ultrasound surrogates and questionnaires, respectively. Retrospective malignant pleural mesothelioma evolution rate was defined by proportion (95% CI). Baseline predictors of evolution were identified using logistic regression.Results 296 patients with AAPI (39 prospective, 257 retrospective) were recruited/selected. 21/39 prospective recruits were histologically diagnosed (target n=27). Repeat LAT was technically feasible and acceptable in 13/28 (46%) and 24/36 (67%) cases with complete follow-up data. Mesothelioma evolution was confirmed histologically in 36/257 retrospective cases (14% (95% CI 10.3% to 18.8%)) and associated with malignant CT features (OR 4.78 (95% CI 2.36 to 9.86)) and age (OR 1.06 (95% CI 1.02 to 1.12)).Conclusions Our initial eligibility criteria were too narrow. Meso-ORIGINS will recruit a broader cohort, including prevalent cases, any biopsy type and patients with malignant CT features. A range of rebiopsy techniques will be allowed, accounting for technical and patient factors. The sample size has been reduced to 500.Trial registration number ISRCTN12840870.https://bmjopen.bmj.com/content/13/8/e067780.full |
| spellingShingle | Selina Tsim Kevin G Blyth Najib M Rahman Nick A Maskell Matthew Evison Rachel Mercer Katie Ferguson Jenny King Matthew Neilson Kelly Marshall Hugh Welch Results of the Meso-ORIGINS feasibility study regarding collection of matched benign-mesothelioma tissue pairs by longitudinal surveillance BMJ Open |
| title | Results of the Meso-ORIGINS feasibility study regarding collection of matched benign-mesothelioma tissue pairs by longitudinal surveillance |
| title_full | Results of the Meso-ORIGINS feasibility study regarding collection of matched benign-mesothelioma tissue pairs by longitudinal surveillance |
| title_fullStr | Results of the Meso-ORIGINS feasibility study regarding collection of matched benign-mesothelioma tissue pairs by longitudinal surveillance |
| title_full_unstemmed | Results of the Meso-ORIGINS feasibility study regarding collection of matched benign-mesothelioma tissue pairs by longitudinal surveillance |
| title_short | Results of the Meso-ORIGINS feasibility study regarding collection of matched benign-mesothelioma tissue pairs by longitudinal surveillance |
| title_sort | results of the meso origins feasibility study regarding collection of matched benign mesothelioma tissue pairs by longitudinal surveillance |
| url | https://bmjopen.bmj.com/content/13/8/e067780.full |
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