NCT00917137

Brief Summary

The main purposes of this study are to assess the performance characteristics of transbronchial needle aspiration (TBNA) in the diagnosis of peripheral pulmonary lesions, and to identify the predictor variables of a positive aspirate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2008

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

July 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 23, 2010

Status Verified

June 1, 2010

Enrollment Period

1.9 years

First QC Date

June 9, 2009

Last Update Submit

June 22, 2010

Conditions

Pulmonary NodulePulmonary Mass

Keywords

Lung cancerLung noduleTransbronchial needle aspirationTransbronchial lung biopsyBronchoscopy

Outcome Measures

Primary Outcomes (1)

  • Assess sensitivity, specificity and accuracy of TBNA in the diagnosis of peripheral pulmonary lesions

    1 year

Secondary Outcomes (2)

  • Evaluate the predictor variables associated with a positive TBNA result

    1 year

  • Compare the performance characteristics of TBNA and transbronchial lung biopsy

    1 year

Study Arms (1)

Peripheral pulmonary lesions

Procedure: TBNA + transbronchial lung biopsy + bronchial washing

Interventions

TBNA + transbronchial lung biopsy + bronchial washingPROCEDURE
Peripheral pulmonary lesions

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with pulmonary nodule or mass referred for bronchoscopy to the Thoracic Endoscopy Unit of Maggiore Hospital (Bologna Italy)

You may qualify if:

  • Age 18 years and older
  • Pulmonary nodule (\< 3 cm) or mass (\> 3 cm) at computed tomography

You may not qualify if:

  • Refusal to sign informed consent
  • Uncontrolled coagulopathy
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maggiore Hospital

Bologna, 40133, Italy

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bronchoalveolar Lavage Fluid

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Bronchoalveolar LavageTherapeutic IrrigationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 10, 2009

Study Start

July 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 23, 2010

Record last verified: 2010-06

Locations

IT(1)