Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Single Scope Staging of Lung Cancer With Endosonography (SCORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02014324
Recruitment Status : Completed
First Posted : December 18, 2013
Last Update Posted : October 20, 2014
Sponsor:
Information provided by (Responsible Party):
Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:

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:

  1. Complete endosonographic (combined endobronchial and esophageal) staging using a single EBUS scope improves locoregional staging (N2, N3, T4) versus EBUS staging alone.
  2. 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

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 215 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
(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.
Procedure: Endosonography

Complete endosonographic mediastinal staging is performed in 2 steps:

  1. Systematic EBUS (airways)
  2. Systematic EUS-B (esophagus)
Other Names:
  • EBUS
  • EUS-B




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • (Suspected) NSCLC;
  • Indication for mediastinal nodal assessment;
  • Suspected mediastinal lymph nodes within reach of EBUS;
  • Age 18 years or older;
  • Clinically fit to undergo surgical resection of the lung tumor;
  • Provision of a written informed consent;

Exclusion Criteria:

  • Mediastinal re-staging after neo-adjuvant treatment;
  • Indication for EUS other than mediastinal staging, eg a for malignancy
  • suspected left adrenal;
  • Active malignancy with a life expectancy of less than two years;
  • Former therapy for lung cancer (chemotherapy, radiotherapy or surgery);
  • Technical contraindication for EBUS or EUS (eg, esophagus stenosis);
  • Pregnancy;
  • Inability to consent;

Information from the National Library of Medicine

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


Locations
Layout table for location information
Belgium
Onze-Lieve-Vrouwen-Ziekenhuis
Aalst, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
Netherlands
Academic Medical Center
Amsterdam, Noord-Holland, Netherlands, 1105AZ
Medisch Centrum Alkmaar
Alkmaar, Netherlands
Antoni van Leeuwenhoek ziekenhuis
Amsterdam, Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands
Leids Universitair Medisch Centrum
Leiden, Netherlands
Universitair Medisch Centrum st Radboud
Nijmegen, Netherlands
Isala klinieken
Zwolle, Netherlands
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Layout table for investigator information
Principal Investigator: Jouke T Annema, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Additional Information:

Layout table for additonal information
Responsible Party: Prof J.T. Annema, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02014324     History of Changes
Other Study ID Numbers: NL42787.018.13
First Posted: December 18, 2013    Key Record Dates
Last Update Posted: October 20, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms