NCT01493739

Brief Summary

This study aims on the combinatorial results of cytology, histopathology and microbiology obatined by EBUS-TBNA for unselected mediastina lesions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2009

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2011

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 16, 2011

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 16, 2011

Status Verified

December 1, 2011

Enrollment Period

3 years

First QC Date

November 21, 2011

Last Update Submit

December 15, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic rate

    Participant will be followed within an average of three months

Study Arms (1)

lymphadenopathy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with mediastinal lymphadenopathy on Chest CT scan with a short-axis \> 10mm

You may qualify if:

  • Age \> 18 years old
  • mediastinal lymphadenopathy on Chest CT scan
  • with a short-axis \> 10mm

You may not qualify if:

  • patients intolerant to bronchoscopy exam
  • unstable vital sign (Blood pressure, heart rate, breath rate)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Chih-Hso Kuo, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chih-Hsi Kuo, MD

CONTACT

Fu-Tsai Chung, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator, Consultant Physician, Respiratory Medicine Department

Study Record Dates

First Submitted

November 21, 2011

First Posted

December 16, 2011

Study Start

January 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

December 16, 2011

Record last verified: 2011-12

Locations