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Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate (TBNA)

This study has been completed.
Sponsor:
Information provided by:
Maine Medical Center
ClinicalTrials.gov Identifier:
NCT00861835
First received: March 12, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Bronchoscopy
Other: ROSE

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: A Randomized Prospective Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate Specimens

Further study details as provided by Maine Medical Center:

Primary Outcome Measures:
  • diagnostic yield [ Designated as safety issue: No ]

Study Start Date: November 2004
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ROSE for TBNA Other: ROSE
rapid on-site evaluation by cytopathology
No Intervention: NR
no on-site cytopathology assessment (NR)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients were to be excluded only if the attending physician felt ROSE must be used for diagnosis or if the patient refused consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Lonny Yarmus, DO, Maine Medical Center
ClinicalTrials.gov Identifier: NCT00861835     History of Changes
Other Study ID Numbers: MMCROSE
Study First Received: March 12, 2009
Last Updated: March 12, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014