NCT02793713

EBUS Score Validation for Malignancy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Neoplasms
• Lung Diseases

Interventions

Type	Name	Description
PROCEDURE	Endobronchial Ultrasound	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.

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-09-17
• Completion: 2017-09-17
• First posted: 2016-06-08
• Last updated: 2018-02-14

Locations

2 sites across 1 country: Canada