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Lung NeoplasmsNCT02793713

EBUS Score Validation for Malignancy

An observational study of Lung Neoplasms and Lung Diseases, run by McMaster University at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Surgical removal of a tumour in the lung offers the best chance for survival in early stage lung cancers. One main criteria of surgical eligibility is the absence of cancer spread to the lymph nodes; rendering the staging process extremely important. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Neoplasms, Lung Diseases
What is being tested?
Endobronchial Ultrasound
Type of treatment
Surgery or procedure
How many people
300 participants
Where
2 sitesCanada
Study dates
Jun 2016to 17 Sep 2017
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 who are diagnosed with suspected or confirmed NSCLC and have been referred to mediastinal staging via EBUS at St. Joseph's Healthcare Hamilton, Toronto General Hospital, Vancouver General Hospital.

Who may be able to join

  • Must be diagnosed with confirmed or suspected lung cancer and be undergoing EBUS diagnosis/staging

Who cannot join

  • N/A

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

Other trials in Canada

About this study

Official title: Prospective Validation of a Malignancy Scoring System During Endoscopic Evaluation of Mediastinal Lymph Nodes for Lung Cancer

Surgical removal of a tumour in the lung offers the best chance for survival in early stage lung cancers. One main criteria of surgical eligibility is the absence of cancer spread to the lymph nodes; rendering the staging process extremely important. The evaluation of these lymph nodes is thought to be best completed using Endobronchial Ultrasound (EBUS), a procedure in which several lymph nodes are sampled and send to pathology to determine whether or not it is malignant. More recently, studies have observed that there are clear differences in the characteristics of cancerous and benign (non-cancerous) lymph nodes, and so there has been great interest in creating a list of criteria that can determine whether a node is malignant. This study aims to prospectively validate a previously proposed score based on observed characteristics of lymph nodes during an EBUS procedure relating to pathology-confirmed results. To test this, the results of the lymph node samples and the observed score will be compared for agreement. If the investigators find that the scoring system can accurately predict which lymph nodes are cancerous, it would provide the evidence to establish the score as a standard procedure during cancer staging.

Being tested
Endobronchial Ultrasound
Keywords
EBUS, Prediction, malignancy, lymph nodes, lung cancer, Diagnostic Techniques, Respiratory System
Medical subject headings
Lung Neoplasms, Lung Diseases, Neoplasms

What participants receive

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

  • Endobronchial UltrasoundProcedure or surgery

    Also called EBUS

    Patients undergoing EBUS with TransBronchial Needle Aspiration will be invited to enroll on the day of their procedure. Once informed consent is obtained, the surgeon will assess the sonographic criteria, take pictures, and biopsy every lymph node of interest. All three elements of this assessment will need to be completed for a specimen to be included in the study. After the procedure, the operating surgeon will fill the Lymph Node Assessment questionnaire, assign an aggregate score to every lymph node specimen, and attach the pictures to the form. Pictures from every specimen will stored electronically to be reviewed and secondarily rated by a second blinded surgeon. Patient involvement in the study ends at the completion of the planned procedure.

What is being measured

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

  1. Internal validity of an aggregate sonographic score

    Objective is to compare the lymph node malignancy predictor score obtained by two raters, one who performed the procedure and the other a secondary rater who viewed the video of the procedure. The score will ideally be similar between raters, showing good inter-rater internal validity.

    Measured: Duration of EBUS procedure (estimated 1 hour)

  2. External validity of an aggregate sonographic score

    As the gold standard for lymph node assessment is via tissue sampling obtained during an EBUS (or other invasive method) procedure, the scores obtained using the lymph node malignancy predictor scoring technique will be compared to later post-surgical pathological staging. The score will be considered to have good criterion (external) validity if there is a high degree of agreement between the pathology and score values.

    Measured: From time of EBUS procedure to date of surgery (expected to be up to 1 month)

Secondary outcomes (2)

  1. Rate of staging re-intervention after initial EBUS

    If the original tissue samples taken during the EBUS procedure were found to be insufficient to rule out malignancy, the patient may undergo another EBUS, or will undergo an Endoscopic ultrasound or a mediastinoscopy. During these follow-up procedures, the surgeon would be obtaining additional tissue in the hope that a result can be made. These re-intervention is not without a risk of adverse events, and ideally should be minimized. We will be abstracting re-intervention occurrences from patient charts.

    Measured: Up to 12 months

  2. Correlation between lymph node aggregate sonographic score and Positron Emission Tomography-elicited Standardized Uptake Values (SUVs)

    All patients undergo Positron Emission Tomography in the course of their clinical staging for suspected lung cancer. The values obtained from this diagnostic test (Standardized Uptake Values [SUVs]) will be obtained and compared to the surgeon's observed score on the lymph node aggregate sonographic scoring tool to investigate whether there is any relationship between the score and the SUVs.

    Measured: From first presentation for diagnosis to date of surgery (Estimated to be 2-3 months)

Timeline

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

  1. First posted8 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completion17 Sep 2017
  4. Study completion17 Sep 2017

Resources

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
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02793713
Sponsor's protocol ID
EBUS_ScoreValidation
Status last verified
Feb 2018
First submitted
3 Jun 2016
Last updated
14 Feb 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • American College of Chest Physicians; Health and Science Policy Committee. Diagnosis and management of lung cancer: ACCP evidence-based guidelines. American College of Chest Physicians. Chest. 2003 Jan;123(1 Suppl):D-G, 1S-337S. No abstract available.

    PubMed 12527560

  • Hanna WC, Yasufuku K. Bronchoscopic staging of lung cancer. Ther Adv Respir Dis. 2013 Apr;7(2):111-8. doi: 10.1177/1753465812468041. Epub 2012 Dec 20.

    PubMed 23258501

  • Schmid-Bindert G, Jiang H, Kahler G, Saur J, Henzler T, Wang H, Ren S, Zhou C, Pilz LR. Predicting malignancy in mediastinal lymph nodes by endobronchial ultrasound: a new ultrasound scoring system. Respirology. 2012 Nov;17(8):1190-8. doi: 10.1111/j.1440-1843.2012.02223.x.

    PubMed 22789110

  • Shafiek H, Fiorentino F, Peralta AD, Serra E, Esteban B, Martinez R, Noguera MA, Moyano P, Sala E, Sauleda J, Cosio BG. Real-time prediction of mediastinal lymph node malignancy by endobronchial ultrasound. Arch Bronconeumol. 2014 Jun;50(6):228-34. doi: 10.1016/j.arbres.2013.12.002. Epub 2014 Feb 8. English, Spanish.

    PubMed 24512940

  • Wang L, Wu W, Hu Y, Teng J, Zhong R, Han B, Sun J. Sonographic Features of Endobronchial Ultrasonography Predict Intrathoracic Lymph Node Metastasis in Lung Cancer Patients. Ann Thorac Surg. 2015 Oct;100(4):1203-9. doi: 10.1016/j.athoracsur.2015.04.143. Epub 2015 Jul 28.

    PubMed 26228606

  • El-Sherief AH, Lau CT, Wu CC, Drake RL, Abbott GF, Rice TW. International association for the study of lung cancer (IASLC) lymph node map: radiologic review with CT illustration. Radiographics. 2014 Oct;34(6):1680-91. doi: 10.1148/rg.346130097.

    PubMed 25310423

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Neoplasms and Lung Diseases, run by McMaster University at 2 sites in Canada.

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 1 inclusion and 1 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 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. 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?

Internal validity of an aggregate sonographic score (time frame: Duration of EBUS procedure (estimated 1 hour)). The study lists 2 primary outcomes in all. 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 NCT02793713, which also lists 6 linked publications.

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 14 Feb 2018.

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