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Short- and Mid-term Therapeutic, Prognostic, and Societal Impact of Implementing Intraoperative Assessment of Pulmonary Resection Quality for Lung Cancer
Sponsor: Fondation Hôpital Saint-Joseph
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2400
Start Date
2026-09-01
Completion Date
2030-03-01
Last Updated
2026-09-18
Healthy Volunteers
No
Conditions
Interventions
QualitySurg List
The QualitySurg List is a collaborative intraoperative quality assessment tool for lung cancer surgery that combines a checklist, a to-do list, and a reporting system. The intervention includes implementation of the QualitySurg List, training of operating room personnel, access to a dedicated digital application integrated within the Epithor platform, and performance feedback through benchmarking of quality indicators. The tool is designed to support real-time assessment and documentation of surgical quality and to improve achievement of oncologically complete (R0) resections.
Locations (20)
CHU Angers
Angers, France
Avicennes
Bobigny, France
CHU Bordeaux
Bordeaux, France
CLCC Jean Perrin
Clermont-Ferrand, France
CHU Dijon
Dijon, France
Hôpital Marie Lannelongue
Le Plessis-Robinson, France
CHU Lille
Lille, France
Chu Lyon
Lyon, France
Hôpital Nord
Marseille, France
CHU Nantes
Nantes, France
Bichat Claude-Bernard
Paris, France
HEGP
Paris, France
Hôpital Tenon
Paris, France
CHU Poitiers
Poitiers, France
CHU de Rennes
Rennes, France
CHU Rouen
Rouen, France
CHU Strasbourg
Strasbourg, France
Hôpital Foch
Suresnes, France
CHU Toulouse
Toulouse, France
CHU Tours
Tours, France