EBUS Score Validation for Malignancy

February 13, 2018 updated by: McMaster University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Internal validity of an aggregate sonographic score
Time Frame: Duration of EBUS procedure (estimated 1 hour)
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.
Duration of EBUS procedure (estimated 1 hour)
External validity of an aggregate sonographic score
Time Frame: From time of EBUS procedure to date of surgery (expected to be up to 1 month)
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.
From time of EBUS procedure to date of surgery (expected to be up to 1 month)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of staging re-intervention after initial EBUS
Time Frame: Up to 12 months
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.
Up to 12 months
Correlation between lymph node aggregate sonographic score and Positron Emission Tomography-elicited Standardized Uptake Values (SUVs)
Time Frame: From first presentation for diagnosis to date of surgery (Estimated to be 2-3 months)
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.
From first presentation for diagnosis to date of surgery (Estimated to be 2-3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Vancouver General Hospital
Toronto General Hospital

Investigators

  • Principal Investigator: Wael C Hanna, MDCM MBA, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ACTUAL)

September 17, 2017

Study Completion (ACTUAL)

September 17, 2017

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

June 3, 2016

First Posted (ESTIMATE)

June 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBUS_ScoreValidation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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