NCT00861835

Brief Summary

Purpose: Previous studies suggested an increased diagnostic yield for bronchoscopic (FB) transbronchial needle aspirate (TBNA) specimens from mediastinal lymph nodes when using rapid on-site evaluation by cytopathology (ROSE) but were limited by lack of randomization. The investigators performed the first randomized-prospective trial comparing ROSE(R) to no on-site cytopathology assessment (NR). Methods: All patients referred were eligible. 78 patients were randomized to R or NR groups. For R procedures, further specimens were deferred until results were available from the on-site cytopathologist. Diagnoses made by all procedures were recorded. The primary end-points were specimen adequacy and diagnostic yield.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 2004

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
Last Updated

March 13, 2009

Status Verified

March 1, 2009

Enrollment Period

3 years

First QC Date

March 12, 2009

Last Update Submit

March 12, 2009

Conditions

Bronchoscopy

Outcome Measures

Primary Outcomes (1)

  • diagnostic yield

Study Arms (2)

ROSE for TBNA

EXPERIMENTAL
Other: ROSE

NR

NO INTERVENTION

no on-site cytopathology assessment (NR)

Interventions

ROSEOTHER

rapid on-site evaluation by cytopathology

ROSE for TBNA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible patients included all adults referred for bronchoscopy with anticipated TBNA.

You may not qualify if:

  • Patients were to be excluded only if the attending physician felt ROSE must be used for diagnosis or if the patient refused consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 12, 2009

First Posted

March 13, 2009

Study Start

November 1, 2004

Primary Completion

November 1, 2007

Study Completion

December 1, 2007

Last Updated

March 13, 2009

Record last verified: 2009-03