Non Small Cell Lung CancerSCORACLENCT07538947
Real-Time Imaging to Improve Lung Cancer Diagnosis : Comparing Confocal Laser Endomicroscopy (CLE) With Standard Biopsy for Quicker and Safer Detection of Non-Small Cell Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The goal of this observational study is to evaluate whether confocal laser endomicroscopy (CLE) can improve the real-time diagnosis of non-small cell lung cancer (NSCLC) in patients undergoing bronchoscopic biopsy for suspected lung tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- bronchoscopic navigation with CLE
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2026to 15 Jun 2026
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients at CHRU de Nancy scheduled for endobronchial navigation-guided biopsy due to suspected lung lesions
Who may be able to join
- Patient for whom endobronchial navigation-guided biopsy is indicated
- Complete medical data (CLE images and histopathological results)
Who cannot join
- Persons referred to in Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code:
- Individuals under 18 years of age
- Adult persons subject to legal protection measures (guardianship, curatorship, or judicial protection)
- Adult persons unable to express their consent
- Persons deprived of liberty by judicial or administrative decision, and persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy
Nancy
Lucie SCHNEDECKER, +33 383156167, L.SCHNEDECKER@chru-nancy.fr
About this study
Official title: Confocal Laser Endomicroscopy (CLE) Score for the Detection of Non-Small Cell Lung Cancer (NSCLC) and Rapid Surgical Decision-Making
The goal of this observational study is to evaluate whether confocal laser endomicroscopy (CLE) can improve the real-time diagnosis of non-small cell lung cancer (NSCLC) in patients undergoing bronchoscopic biopsy for suspected lung tumors. The main questions it aims to answer are:
- Can a high-specificity CLE-based score accurately identify NSCLC during endoscopic procedures?
- Can CLE imaging criteria improve biopsy yield and help differentiate histological subtypes (e.g., squamous cell carcinoma, adenocarcinoma, carcinoid tumors)?
Read more
Participants will:
- Undergo standard bronchoscopic navigation procedures with additional real-time imaging using CLE and biopsy
- Have CLE findings compared with standard histopathological analysis of biopsy samples
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- bronchoscopic navigation with CLE
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoscopic navigation with CLEProcedure or surgery
bronchoscopic navigation with real-time imagine (Confocal Laser Endomicroscopy)
| Study group | Role | What they receive |
|---|---|---|
| CLE based bronchoscopic navigation Group | Not described Receives: Procedure: bronchoscopic navigation with CLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the CLE-based score for non-small cell lung cancer (NSCLC) detection
Proportion of cases in which the CLE imaging score correctly identifies NSCLC, using standard histopathology from biopsy samples as the reference standard
Measured: During the endoscopic procedure and confirmed after biopsy analysis (up to 7 days)
Secondary outcomes (2)
Improvement of biopsy yield using CLE imaging criteria
Proportion of biopsy samples considered adequate for histopathological diagnosis when guided by CLE imaging features.
Measured: During the endoscopic procedure and confirmed after pathology analysis (up to 7 days)
Identification of NSCLC histological subtypes using CLE imaging
Accuracy of CLE imaging criteria in differentiating NSCLC subtypes (e.g., squamous cell carcinoma, adenocarcinoma, carcinoid tumors) compared with standard histopathology.
Measured: During the procedure and confirmed after biopsy analysis (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start3 Apr 2026
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SCHNEDECKER Lucie, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538947
- Sponsor's protocol ID
- 2025PI085
- Acronym
- SCORACLE
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Laser Endomicroscopy (CLE) Score for the Detection of Non-Small Cell Lung Cancer (NSCLC) and Rapid Surgical Decision-Making
- ClinicalTrials.gov ID
- NCT07538947
- Acronym / sponsor ID
- SCORACLE / 2025PI085
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 20 Apr 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.
The goal of this observational study is to evaluate whether confocal laser endomicroscopy (CLE) can improve the real-time diagnosis of non-small cell lung cancer (NSCLC) in patients undergoing bronchoscopic biopsy for suspected lung tumors. The main questions it aims to answer are:
- Can a high-specificity CLE-based score accurately identify NSCLC during endoscopic procedures?
- Can CLE imaging criteria improve biopsy yield and help differentiate histological subtypes (e.g., squamous cell carcinoma, adenocarcinoma, carcinoid tumors)?
Participants will:
- Undergo standard bronchoscopic navigation procedures with additional real-time imaging using CLE and biopsy
- Have CLE findings compared with standard histopathological analysis of biopsy samples
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLE based bronchoscopic navigation Group | – | Procedure: bronchoscopic navigation with CLE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients at CHRU de Nancy scheduled for endobronchial navigation-guided biopsy due to suspected lung lesions
Key inclusion criteria (2 listed)
- Patient for whom endobronchial navigation-guided biopsy is indicated
- Complete medical data (CLE images and histopathological results)
Key exclusion criteria (5 listed)
- Persons referred to in Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code:
- Individuals under 18 years of age
- Adult persons subject to legal protection measures (guardianship, curatorship, or judicial protection)
- Adult persons unable to express their consent
- Persons deprived of liberty by judicial or administrative decision, and persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1
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 |
|---|---|---|
| bronchoscopic navigation with CLEbronchoscopic navigation with real-time imagine (Confocal Laser Endomicroscopy) | Procedure or surgery | CLE based bronchoscopic navigation Group |
Primary outcome
Diagnostic accuracy of the CLE-based score for non-small cell lung cancer (NSCLC) detection
Time frame: During the endoscopic procedure and confirmed after biopsy analysis (up to 7 days)
Proportion of cases in which the CLE imaging score correctly identifies NSCLC, using standard histopathology from biopsy samples as the reference standard
2 secondary outcomes
Improvement of biopsy yield using CLE imaging criteria
Time frame: During the endoscopic procedure and confirmed after pathology analysis (up to 7 days)
Identification of NSCLC histological subtypes using CLE imaging
Time frame: During the procedure and confirmed after biopsy analysis (up to 7 days)
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 20 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Central Hospital, Nancy, France at 1 site 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Lucie Schnedecker (+33 383156167, L.SCHNEDECKER@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the CLE-based score for non-small cell lung cancer (NSCLC) detection (time frame: During the endoscopic procedure and confirmed after biopsy analysis (up to 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2026.