An interventional study of QualitySurg List in Lung Cancer (Non-Small Cell), sponsored by Fondation Hôpital Saint-Joseph. Not yet recruiting at 20 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Fondation Hôpital Saint-Joseph · Not applicable, Interventional, and Other
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.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 2,400 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Fondation Hôpital Saint-Joseph is the lead sponsor of 346 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Proportion of Confirmed R0 Resections
R0 status assessed according to IASLC 2020 criteria using centralized pathology review and independent adjudication.
Time frame: Perioperative
QualitySurg list Implementation and Adoption
Measure individual and collective adherence to the list (usage rate, level of completeness).
Time frame: During surgery
Medium-Term Oncological Results
overall survival (OS) and disease-free survival (DFS) at 2 years, and proportion of local or metastatic recurrences at 2 years.
Time frame: 2 years after surgery
Quality of the Surgical Procedure
Evaluate the impact on intraoperative and post-operative complications (morbidity, mortality, length of stay, especially in intensive care).
Time frame: 30 and 90 days after surgery
Sociological and Collaborative Aspects
Evaluate the impact on: * Interprofessional communication : obeservations, semi-structured interviews, self-administred questionnaire (Likert scale) * Team engagement: obeservations, semi-structured interviews, self-administred questionnaire (Likert scale) * Acceptability of the list in the operating room: obeservations, semi-structured interviews, self-administred questionnaire (Likert scale)
Time frame: During surgery
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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