Evaluation of Endobronchial Ultrasound (EBUS) for Staging... | NCT01799980

Studies
Evaluation of Endobronchial Ultrasound (EBUS) for Staging Lung Cancer

NCT01799980

Sponsor

Ottawa Hospital Research Institute

Status

Completed

Last Update Posted

Mar 21, 2019Actual

Enrollment

37Actual

Phase

Not provided

Conditions

Lung Cancer

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Feb 25, 2013

First Submission Date that Met QC Criteria

Feb 25, 2013

First Posted Date

Feb 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2019

Last Update Posted Date

Mar 21, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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).

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Donna E Maziak, MD, MSc	Ottawa Hospital Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ottawa Hospital Research Institute		Ottawa	Ontario	K1H8L6	Canada

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided