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

NCT07828938 | Not Yet Recruiting

• 1 other identifier: 2025-A01703-46
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Lung Cancer (Non-Small Cell)

Keywords

Thoracic surgery; lung cancer; checklist; R0 resection

Outcome Measures

Primary Outcomes (1)

• Proportion of Confirmed R0 Resections

  R0 status assessed according to IASLC 2020 criteria using centralized pathology review and independent adjudication.

  Perioperative

Secondary Outcomes (4)

• QualitySurg list Implementation and Adoption

  During surgery

• Medium-Term Oncological Results

  2 years after surgery

• Quality of the Surgical Procedure

  30 and 90 days after surgery

• Sociological and Collaborative Aspects

  During surgery

Study Arms (2)

QualitySurg Implementation Strategy

EXPERIMENTAL

Centers assigned to the intervention arm will first participate in a baseline control period during which eligible patients undergo lung cancer surgery according to usual practice without use of the QualitySurg list. During a subsequent intervention period, centers will implement the QualitySurg list, a structured intraoperative quality assessment tool combining a checklist, a to-do list, and a reporting system, supported by training, digital reporting tools, and performance feedback. Following completion of the randomized trial phase, centers will enter a prospective implementation phase in which continued, partial, modified, or discontinued use of the QualitySurg list will be observed under routine clinical practice conditions in order to assess maintenance of use and long-term adoption.

Other: QualitySurg List

Standard Surgical Practice

NO INTERVENTION

Centers assigned to the control arm will continue their usual surgical practice throughout the randomized trial phase without implementation of the QualitySurg list. Following completion of the randomized trial phase, the QualitySurg list will be made available to these centers. During the subsequent prospective implementation phase, uptake, integration, patterns of use, and adoption of the QualitySurg list will be evaluated under routine clinical practice conditions without any mandatory requirement for implementation.

Interventions

QualitySurg List OTHER

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.

QualitySurg Implementation Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (20)

CHU Angers

Angers, France

Location

Avicennes

Bobigny, France

Location

CHU Bordeaux

Bordeaux, France

Location

CLCC Jean Perrin

Clermont-Ferrand, France

Location

CHU Dijon

Dijon, France

Location

Hôpital Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

CHU Lille

Lille, France

Location

Chu Lyon

Lyon, France

Location

Hôpital Nord

Marseille, France

Location

CHU Nantes

Nantes, France

Location

Bichat Claude-Bernard

Paris, France

Location

HEGP

Paris, France

Location

Hôpital Tenon

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

CHU de Rennes

Rennes, France

Location

CHU Rouen

Rouen, France

Location

CHU Strasbourg

Strasbourg, France

Location

Hôpital Foch

Suresnes, France

Location

CHU Toulouse

Toulouse, France

Location

CHU Tours

Tours, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Olaf MERCIER

CONTACT

0033140948695; o.mercier@ghpsj.fr

Imène TRIAKI

CONTACT

0033140942330; itriaki@ghpsj.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: September 18, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (20)