NCT01799980

Brief Summary

This study will compare two different methods of staging lung cancer to determine whether endobronchial ultrasound (EBUS) staging of mediastinal lymph nodes will provide good diagnostic yield in detecting lung cancer, when compared to current methods of a staging bronchoscopy and cervical mediastinoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

6.5 years

First QC Date

February 25, 2013

Last Update Submit

March 19, 2019

Conditions

Lung Cancer

Keywords

Lung cancerCervical mediastinoscopyEndobronchial ultrasoundStaging

Outcome Measures

Primary Outcomes (1)

  • Lung cancer staging

    Lung cancer staging (assessed by either cervical mediastinoscopy or EBUS) will be compared both pre-op and post-op.

    Pre-op and post-op

Study Arms (2)

Cervical mediastinoscopy

This group will undergo cervical mediastinoscopy before surgery to stage their lung cancer (procedure decided by the surgeon).

Endo-bronchial ultrasound

This group will undergo endobronchial ultrasound before surgery to stage their lung cancer (procedure decided by the surgeon).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing a staging procedure for lung cancer (either cervical mediastinoscopy or endobronchial ultrasound).

You may qualify if:

  • Patients, \> 18 years of age,
  • Gender- Males and Female
  • Diagnosis of Non Small Cell Lung Cancer.
  • Patients who have consented on an Ottawa Hospital consent form to undergo a mediastinoscopy procedure or EBUS-TBNA, and a Positron emission tomography (PET) of the chest for lung cancer staging.

You may not qualify if:

  • Females who are pregnant (or found to be pregnant) during the course of this research study.
  • Patients who do not provide their Ottawa Hospital consent to undergo a staging bronchoscopy , cervical mediastinoscopy or EBUS-TBNA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H8L6, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Donna E Maziak, MD, MSc

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2013

First Posted

February 27, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 21, 2019

Record last verified: 2019-03

Locations

CA(1)