EBUS Score Validation for Malignancy

Completed

• Conditions: Lung Neoplasms; Lung Diseases

• Registration Number: NCT02793713
• Lead Sponsor: McMaster University

Brief 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. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-03
• Study First Submitted QC: 2016-06-03
• Study First Posted: 2016-06-08
• Primary Completion: 2017-09-17
• Study Completion: 2017-09-17
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

• N/A

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
External validity of an aggregate sonographic score	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.
Internal validity of an aggregate sonographic score	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.

Secondary Outcome Measures

Name	Time	Method
Correlation between lymph node aggregate sonographic score and Positron Emission Tomography-elicited Standardized Uptake Values (SUVs)	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.
Rate of staging re-intervention after initial EBUS	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.

Trial Locations

Locations (2)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada