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NCT07828938
Short- and Mid-term Therapeutic, Prognostic, and Societal Impact of Implementing Intraoperative Assessment of Pulmonary Resection Quality for Lung Cancer
Conditions: Lung Cancer (Non-Small Cell)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 2400
Sponsor: Fondation Hôpital Saint-Joseph
Location: CHU Angers Angers
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 Criteria
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
Source: ClinicalTrials.gov (NCT07828938). StuddyBuddy aggregates publicly available trial information.