EBUS Score Validation for Malignancy

NCT ID: NCT02793713

Last Updated: 2018-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-09-17

Brief Summary

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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

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Conditions

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Lung Neoplasms Lung Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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EBUS

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Toronto General Hospital

OTHER

Sponsor Role collaborator

Vancouver General Hospital

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wael C Hanna, MDCM MBA

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 12527560 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23258501 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22789110 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24512940 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26228606 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25310423 (View on PubMed)

Other Identifiers

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EBUS_ScoreValidation

Identifier Type: -

Identifier Source: org_study_id

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