Clinical trial · Interventional
Short- and Mid-term Therapeutic, Prognostic, and Societal Impact of Implementing Intraoperative Assessment of Pulmonary Resection Quality for Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer (Non-Small Cell) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QualitySurg List | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- QualitySurg Implementation Strategy
- description
- 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.
- interventionNames
- Other: QualitySurg List
- type
- NO_INTERVENTION
- label
- Standard Surgical Practice
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available