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Clinical Trials in France / NCT07828938
Starting soon Not applicable

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

NCT07828938 · tracked via the Priya Life Science France tracker
Sponsor
Fondation Hôpital Saint-Joseph
Phase
Not applicable
Started
2026-09-01
Last updated
2026-09-18

Condition(s) studied

Lung Cancer (Non-Small Cell)

Investigational drug(s) / intervention(s)

QualitySurg List

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥18 years * Have solid NSCLC clinical stage IA-IIIA (according to the 9th edition of the TNM) and be eligible for surgical resection. * Have a respiratory function and a state of performance (ECOG) allowing the surgical procedure. * Primary intervention for NSCLC, whether isolated or included in a multimodal regimen (neoadjuvant/adjuvant). * Intervention can be performed by minimally invasive surgery (VATS, RATS) or by thoracotomy. * Have given written informed consent. Exclusion Criteria: * History of cancer less than five years old excluding non-melanocytic skin cancer prior to enrollment * Pure ground glass opacities regardless of tumor size * iterative re-interventions of the same stay (keep only the first planned intervention for the main analysis) * History of HIV infection, allogeneic stem cell or solid organ transplant * History of any hematological disease that is not considered to be in complete remission * Patients under guardianship or conservatorship * Patients deprived of their liberty or under judicial protection * Pregnant women

Primary outcome measure(s)

  • Proportion of Confirmed R0 Resections — Perioperative
    R0 status assessed according to IASLC 2020 criteria using centralized pathology review and independent adjudication.

Trial sites (20)

FacilityCityRegionStatus
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

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07828938 on ClinicalTrials.gov ↗ ← All trials in France