Lung Cancer (Non-Small Cell)QualitySurgNCT07828938

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

A study testing QualitySurg List in people with Lung Cancer (Non-Small Cell), run by Fondation Hôpital Saint-Joseph at 20 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer (Non-Small Cell)
What is being tested?: QualitySurg List
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,400 participants
Where: 20 sitesFrance
Study dates: 1 Sep 2026to 1 Mar 2030
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Olaf MERCIER contact

Imène TRIAKI contact

City, postcode or hospital

20 sites in 1 country

France20 sites

CHU Angers
Angers
AMMI Myriam
Avicennes
Bobigny
Emmanuel MARTINOD
CHU Bordeaux
Bordeaux
Yanis BELAROUSSI
CLCC Jean Perrin
Clermont-Ferrand
Marc FILAIRE
CHU Dijon
Dijon
Hôpital Marie Lannelongue
Le Plessis-Robinson, 92350
Olaf Mercier
CHU Lille
Lille
Axel PLAISANT
Chu Lyon
Lyon
Jean Michel MAURY
Hôpital Nord
Marseille
Pascal THOMAS
CHU Nantes
Nantes
Philippe LACOSTE
Bichat Claude-Bernard
Paris
Pierre MORDANT
HEGP
Paris
Hôpital Tenon
Paris
CHU Poitiers
Poitiers
Christophe JAYLE
CHU de Rennes
Rennes
Bertrand RICHARD DE LA TOUR
CHU Rouen
Rouen
Jean-Marc BASTE
CHU Strasbourg
Strasbourg
Pierre-Emmanuel FALCOZ
Hôpital Foch
Suresnes
Edouard SAGE
CHU Toulouse
Toulouse
CHU Tours
Tours
Antoine LEGRAS
Antoine LEGRAS

Other trials in France

About this study

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)
Being tested: QualitySurg List
Keywords: Thoracic surgery, lung cancer, checklist, R0 resection
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QualitySurg ListOther
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 groups in NCT07828938
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

QualitySurg list Implementation and Adoption
Measure individual and collective adherence to the list (usage rate, level of completeness).
Measured: 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.
Measured: 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).
Measured: 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)
Measured: During surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20261 Mar 2030

First posted18 Sep 2026
Study start1 Sep 2026 (estimated)
Primary completion1 Sep 2029 (estimated)
Study completion1 Mar 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung Cancer (Non-Small Cell)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2,400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07828938
Sponsor's protocol ID: 2025-A01703-46
Acronym: QualitySurg
Status last verified: Jul 2026
First submitted: 7 Sep 2026
Last updated: 18 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short- and Mid-term Therapeutic, Prognostic, and Societal Impact of Implementing Intraoperative Assessment of Pulmonary Resection Quality for Lung Cancer
ClinicalTrials.gov ID: NCT07828938
Acronym / sponsor ID: QualitySurg / 2025-A01703-46
Conditions: Lung Cancer (Non-Small Cell)
Keywords: Thoracic surgery, lung cancer, checklist, R0 resection
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 2,400 participants (estimated)
Lead sponsor: Fondation Hôpital Saint-JosephUniversity, hospital or other
Study start: 1 Sep 2026 (estimated)
Primary completion: 1 Sep 2029 (estimated)
Study completion: 1 Mar 2030 (estimated)
First posted: 18 Sep 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
QualitySurg Implementation Strategy	Experimental	Other: QualitySurg ListCenters 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.
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QualitySurg ListThe 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.	Other	QualitySurg Implementation Strategy

Primary outcome

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

4 secondary outcomes

QualitySurg list Implementation and Adoption
Time frame: During surgery
Medium-Term Oncological Results
Time frame: 2 years after surgery
Quality of the Surgical Procedure
Time frame: 30 and 90 days after surgery
Sociological and Collaborative Aspects
Time frame: During surgery

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Olaf MERCIER contact

Imène TRIAKI contact

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing QualitySurg List in people with Lung Cancer (Non-Small Cell), run by Fondation Hôpital Saint-Joseph at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Olaf MERCIER (0033140948695, o.mercier@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Confirmed R0 Resections (time frame: Perioperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07828938.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.