Staging by Thoracoscopy in potentially radically treatable Lung Cancer associated with Minimal Pleural Effusion (STRATIFY): Protocol of a prospective, multicentre, observational study

Ferguson, J. et al. (2023) Staging by Thoracoscopy in potentially radically treatable Lung Cancer associated with Minimal Pleural Effusion (STRATIFY): Protocol of a prospective, multicentre, observational study. BMJ Open Respiratory Research, 10, e001771. (doi: 10.1136/bmjresp-2023-001771) (PMID:37996118) (PMCID:PMC10668291)

Abstract

Introduction: Recurrence rate following radical therapy for lung cancer remains high, potentially reflecting occult metastatic disease, and better staging tools are required. Minimal pleural effusion (mini-PE) is associated with particularly high recurrence risk and is defined as an ipsilateral pleural collection (<1/3 hemithorax on chest radiograph), which is either too small to safely aspirate fluid for cytology using a needle, or from which fluid cytology is negative. Thoracoscopy (local anaesthetic thoracoscopy (LAT) or video-assisted thoracoscopic surgery (VATS)) is the gold-standard diagnostic test for pleural malignancy in patients with larger symptomatic effusions. Staging by Thoracoscopy in potentially radically treatable Lung Cancer associated with Minimal Pleural Effusion (STRATIFY) will prospectively evaluate thoracoscopic staging in lung cancer associated-mini-PE for the first time. Methods and analysis: STRATIFY is a prospective multicentre observational study. Recruitment opened in January 2020. The primary objective is to determine the prevalence of detectable occult pleural metastases (OPM). Secondary objectives include assessment of technical feasibility and safety, and the impact of thoracoscopy results on treatment plans, overall survival and recurrence free survival. Inclusion criteria are (1) suspected/confirmed stages I–III lung cancer, (2) mini-PE, (3) Performance Status 0–2 (4), radical treatment feasible if OPM excluded, (5) ≥16 years old and (6) informed consent. Exclusion criteria are any metastatic disease or contraindication to the chosen thoracoscopy method (LAT/VATS). All patients have LAT or VATS within 7 (±5) days of registration, with results returned to lung cancer teams for treatment planning. Following an interim analysis, the sample size was reduced from 96 to 50, based on a lower-than-expected OPM rate. An MRI substudy was removed in November 2022 due to pandemic-related site setup/recruitment delays. These also necessitated a no-cost recruitment extension until October 2023.

• Item Type: Articles
• Additional Information: Funding: This work was supported by the Chief Scientist’s Office of the Scottish Government (Grant Ref: TCS/18/08).
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Shad, Dr Shumaila and Cowell, Dr Gordon and Tate, Matthew and Blyth, Professor Kevin and Alexander, Mrs Laura and Neilly, Dr Mark and Tsim, Dr Selina and Kelly, Mrs Caroline
• Authors: Ferguson, J., Tsim, S., Kelly, C., Alexander, L., Shad, S., Neilly, M., Tate, M., Zahra, B., Saleh, M., Cowell, G., Banks, E., Grundy, S., Corcoran, J., Downer, N., Stanton, A., Evison, M., Rahman, N., Maskell, N., and Blyth, K.
• College/School: College of Medical Veterinary and Life Sciences > School of Cancer Sciences
• Journal Name: BMJ Open Respiratory Research
• Publisher: BMJ Publishing Group
• ISSN: 2052-4439
• ISSN (Online): 2052-4439
• Copyright Holders: Copyright © The Authors (or their employers) 2023
• First Published: First published in BMJ Open Respiratory Research 10:e001771
• Publisher Policy: Reproduced under a Creative Commons licence

Project Code	Award No	Project Name	Principal Investigator	Funder's Name	Funder Ref	Lead Dept
309770		STRATIFY : Staging by Thoracoscopy in potentially Radically Treatable Non-Small Cell Lung Cancer associated with Minimal Pleural Effusion	Kevin Blyth	Office of the Chief Scientific Adviser (CSO)	TCS/18/08	School of Cancer Sciences