Tovholder / kontaktperson:
Vasiliki Panou, mail: vasiliki.panou@rsyd.dk
Forskningsenhed:
Odense Respiratory Research Unit (ODIN), Lungemedicinsk Afd. J, SDU & OUH
Forskningsleder: professor Christian B. Laursen, mail: christian.b.laursen@rsyd.dk
Forskningsspørgsmål / primære aim:
The aims of this prospective cohort study are to provide platforms for:
1) The improvement in understanding of long-term, patient-reported and objective clinical outcomes in pleural disease, and
2) The evaluation of current and future physiological, biochemical, and radiological biomarkers in the diagnosis and management of patients with pleural disease
For the purpose of this study pleural disease includes pleural effusion and pleural thickening due to benign or malignant pleural disease.
Metode:
The Pleura Project is a prospective, longitudinal cohort study of patients that are under investigation for pleural disease.
Outcomes:
Primary outcomes
- Can proteomic methods be applied to identify new biomarkers for use in the diagnosis, prognosis and/or management of pleural effusion and pleural thickening?
- Can immunohistochemistry be applied to identify new biomarkers for use in the diagnosis, prognosis and/or management of pleural effusion and pleural thickening?
- Can existing laboratory or point-of-care tests, including enzyme-linked immunosorbent assays (ELISA) be applied to identify (or improve) biomarkers or scoring systems for use in the diagnosis, prognosis and/or management of pleural effusion and pleural thickening?
- Can histopathological and cytological methods be applied to identify or improve biomarkers for use in the diagnosis, prognosis and/or management of pleural effusion and pleural thickening?
- Can single-cell sequencing methods be applied to identify or improve biomarkers for use in the diagnosis, prognosis and/or management of pleural thickening?
Secondary outcomes
Clinical outcomes
- What is the average survival for patients with benign pleural effusion and pleural thickening?
- What is the average survival for patients with malignant pleural effusion and pleural thickening?
- What is the average number of interventions required to confirm the presence/absence of malignant pleural effusion and pleural thickening?
- Which factors predict survival and/or progression in patients with malignant pleural effusion and pleural thickening?
- What is the incidence of complications following pleural drainage and pleural aspiration and pleural biopsy?
- Which factors pre-dispose to the presence/development of non-expandable lung?
- Which factors pre-dispose to the presence/development of pleural fluid septation and loculation?
- Which factors pre-dispose to successful/unsuccessful pleurodesis?
- Which factors influence the development, rate and volume of pleural fluid production?
- What are the healthcare costs associated with benign pleural effusion and pleural thickening?
- What are the healthcare costs associated with malignant pleural effusion and pleural thickening?
Radiological biomarkers
- Can thoracic ultrasound be used to predict clinical outcomes in pleural effusion and pleural thickening?
- Can Computed Tomography (CT) be used to predict clinical outcomes in pleural effusion and pleural thickening?
- Can 18-Fluoro-Deoxyglucose Positron Emission Tomography (FDG PET) be used to predict clinical outcomes in pleural effusion and pleural thickening?
- Can Magnetic Resonance Imaging (MRI) be used to predict clinical outcomes in pleural effusion and pleural thickening?
- Can novel radiological software (e.g., artificial intelligence software) be applied to routinely acquired images to improve diagnostics and guide management of pleural effusion and pleural thickening?
- What are the relative diagnostic rates of the imaging modalities used in pleural effusion and pleural thickening?
Physiological biomarkers
- Can clinical markers/scores of general frailty be applied to patients with pleural effusion and pleural thickening?
- Can lung function tests be used to predict clinical outcomes in pleural effusion and pleural thickening?
- Can reported activity levels be used to predict clinical outcomes in pleural effusion and pleural thickening?
Projekt status / tidsplan:
Patient inklusion påbegyndes i 2026
Funding på plads:
Delvist.
Deltagende centre:
Odense Universitetshospital
Sygehus Lillebælt, Vejle
North Bristol National Health Service Trust, Southmead Hospital, Bristol, UK
Projekt åbent for deltagelse af flere centre:
Ja