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NOT YET RECRUITING
NCT07828938
NA

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

View on ClinicalTrials.gov

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

Interventions

OTHER

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