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Short- and Mid-term Therapeutic, Prognostic, and Societal Impact of Implementing Intraoperative Assessment of Pulmonary Resection Quality for Lung Cancer

Study acronym: QualitySurg
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

  1. Minor Study First Submitted
QUALITYSURG is a multicenter interventional study evaluating whether a collaborative intraoperative quality checklist (QualitySurg List) can improve the oncological quality of lung cancer resections. The study includes three phases: a Delphi consensus to define checklist contents, a cluster-randomized trial comparing checklist use versus standard care, and a prospective implementation phase assessing long-term adoption. The primary endpoint is the proportion of confirmed R0 resections according to 2020 IASLC criteria.Two optional ancillary studies are embedded within the main protocol. BIO-QualitySurg aims to evaluate biological markers of residual disease and develop the concept of a biological R0 resection using circulating tumor DNA (ctDNA), tissue biomarkers, and integrated molecular analyses. BIO-QualitySurg is complementary to the objectives of the European REALCARE project, which investigates ctDNA-based approaches for residual disease assessment and personalized cancer management. VIDEO-QualitySurg contributes to the broader objective of improving quality assessment and standardization of thoracic oncologic surgery through digital technologies and artificial intelligence.
Trial Details
NCT Number NCT07828938
Lead Sponsor Fondation Hôpital Saint-Joseph
Conditions
(from sponsor)
Lung Cancer (Non-Small Cell)
Related terms Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
Enrollment 2,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov