Single Scope Staging of Lung Cancer With Endosonography (SCORE)
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|ClinicalTrials.gov Identifier: NCT02014324|
Recruitment Status : Completed
First Posted : December 18, 2013
Last Update Posted : October 20, 2014
Rationale: Lung cancer is the most commonly diagnosed cancer worldwide and is the most frequent cause of cancer death. Accurate staging is important because it directs treatment and prognosis. Mediastinal staging can be done by both EBUS-TBNA and EUS-FNA. These two techniques have a complementary diagnostic range and the combined procedure is suited for assessment of almost the entire mediastinum. In practice, when mediastinal tissue staging is indicated, endoscopists often perform either an EBUS or an EUS investigation (instead of the combined procedure). Second, frequently only one or two, by imaging suspected lymph node stations, are sampled (ie. targeted approach).
Objectives: main and secondary:
- Complete endosonographic (combined endobronchial and esophageal) staging using a single EBUS scope improves locoregional staging (N2, N3, T4) versus EBUS staging alone.
- Systematic mediastinal staging results in improved locoregional staging compared to PET-CT directed assessment of the mediastinum (ie targeted approach).
Study population: Patients with potentially operable and resectable NSCLC are eligible if there is an indication for mediastinal nodal sampling. Patients have an indication for EBUS-TBNA.
Intervention: Patients will undergo an EBUS investigation followed by EUS-B in the same session. During this single scope procedure, lymph nodes that are suspected on prior CT-PET imaging and on subsequent ultrasound are sampled.
Main study endpoint: The main study parameter is the sensitivity for locoregional disease (N2, N3, T4 disease) of complete endosonographic staging (by EBUS-TBNA and EUS-B-FNA) in comparison with EBUS staging alone.
|Condition or disease||Intervention/treatment|
|Non Small Cell Lung Cancer (NSCLC) Indication Mediastinal Staging Complete Endosonography||Procedure: Endosonography|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||215 participants|
|Target Follow-Up Duration:||4 Weeks|
|Official Title:||Complete Endosonographic Staging of Lung Cancer: a Systematic Single Scope Approach|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
(suspected) NSCLC, mediastinal staging, endosonography
Patients with potentially medically operable and resectable NSCLC are eligible if there is an indication for pathological evaluation of mediastinal lymph nodes.
Complete endosonographic mediastinal staging is performed in 2 steps:
- Sensitivity for locoregional disease (N2, N3, T4 disease). [ Time Frame: from inclusion untill either pathological proof of mediastinal metastases by endospnography or 1 week after surgical verification ]
Sensitivity is defined as number of true positives (pathologic proof of a nodal metastases) divided by the number of true positives and false negatives (thoracotomy with nodal dissection is the reference standard to detect false negatives).
The main study parameter is the sensitivity for locoregional disease (N2, N3, T4 disease) of complete endosonographic staging (by EBUS-TBNA and EUS-B-FNA) in comparison with EBUS staging alone.
In the event of pathological proof of mediastinal metastases (N2/N3) by endosonography patients are classified as having locally advanced disease (stage III) and the study stops. When no mediastinal metastases are found by endosonography, surgical verification will take place (reference standard).
- Sensitivity for locally advanced disease (N2-3 metastases, T4). Systematic assessment and sampling of mediastinal lymph nodes versus PET-CT directed assessment of the mediastinum. [ Time Frame: from inclusion untill either pathological proof of mediastinal metastases by endosonography or 1 week after surgical verification ]Sensitivity for locally advanced disease (N2-3 metastases, T4) of systematic assessment and sampling of mediastinal lymph nodes in comparison to PET-CT directed assessment of the mediastinum (ie targeted approach).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014324
|Universitair Ziekenhuis Leuven|
|Academic Medical Center|
|Amsterdam, Noord-Holland, Netherlands, 1105AZ|
|Medisch Centrum Alkmaar|
|Antoni van Leeuwenhoek ziekenhuis|
|Vrije Universiteit Medisch Centrum|
|Leids Universitair Medisch Centrum|
|Universitair Medisch Centrum st Radboud|
|Principal Investigator:||Jouke T Annema, MD, PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|