Non Small Cell Lung Cancer (NSCLC)SCORENCT02014324
Single Scope Staging of Lung Cancer With Endosonography
An observational study of Non Small Cell Lung Cancer (NSCLC) and Indication Mediastinal Staging, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer (NSCLC), Indication Mediastinal Staging, Complete Endosonography
- What is being tested?
- Endosonography
- Type of treatment
- Surgery or procedure
- How many people
- 215 participants
- Where
- 9 sitesin 2 countries
- Study dates
- May 2013to Oct 2014
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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
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.
Who may be able to join
- (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;
Who cannot join
- 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;
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Netherlands7 sites
Medisch Centrum Alkmaar
Alkmaar
Academic Medical Center
Amsterdam, North Holland, 1105AZ
Antoni van Leeuwenhoek ziekenhuis
Amsterdam
Vrije Universiteit Medisch Centrum
Amsterdam
Leids Universitair Medisch Centrum
Leiden
Universitair Medisch Centrum st Radboud
Nijmegen
Isala klinieken
Zwolle
Belgium2 sites
Onze-Lieve-Vrouwen-Ziekenhuis
Aalst
Universitair Ziekenhuis Leuven
Leuven
About this study
Official title: Complete Endosonographic Staging of Lung Cancer: a Systematic Single Scope Approach
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:
Read more
- 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.
- Conditions
- Non Small Cell Lung Cancer (NSCLC), Indication Mediastinal Staging, Complete Endosonography
- Being tested
- Endosonography
- 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.
EndosonographyProcedure or surgery
Also called EBUS, EUS-B
Complete endosonographic mediastinal staging is performed in 2 steps:
- Systematic EBUS (airways)
- Systematic EUS-B (esophagus)
| Study group | Role | What they receive |
|---|---|---|
| (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. Receives: Procedure: Endosonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for locoregional disease (N2, N3, T4 disease).
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).
Measured: from inclusion untill either pathological proof of mediastinal metastases by endospnography or 1 week after surgical verification
Secondary outcomes (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.
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).
Measured: from inclusion untill either pathological proof of mediastinal metastases by endosonography or 1 week after surgical verification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2014
- Study completionOct 2014
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 Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Prospective
- Enrolment
- 215 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jouke T Annema, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014324
- Sponsor's protocol ID
- NL42787.018.13
- Acronym
- SCORE
- Status last verified
- Oct 2014
- First submitted
- 30 May 2013
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Endosonographic Staging of Lung Cancer: a Systematic Single Scope Approach
- ClinicalTrials.gov ID
- NCT02014324
- Acronym / sponsor ID
- SCORE / NL42787.018.13
- Conditions
- Non Small Cell Lung Cancer (NSCLC), Indication Mediastinal Staging, Complete Endosonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 18 Dec 2013 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (suspected) NSCLC, mediastinal staging, endosonography | – | Procedure: EndosonographyPatients with potentially medically operable and resectable NSCLC are eligible if there is an indication for pathological evaluation of mediastinal lymph nodes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- (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;
Key exclusion criteria (8 listed)
- 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);
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 |
|---|---|---|
| EndosonographyAlso: EBUS, EUS-BComplete endosonographic mediastinal staging is performed in 2 steps: 1. Systematic EBUS (airways) 2. Systematic EUS-B (esophagus) | Procedure or surgery | (suspected) NSCLC, mediastinal staging, endosonography |
Primary outcome
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
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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. This study is not recruiting at the moment.
Jouke T Annema, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
9 sites in 2 countries: 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 (NSCLC) and Indication Mediastinal Staging, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 9 sites in 2 countries.
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: finished, as of the sponsor's last update on 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands, Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 Oct 2014.