NCT02157194

Brief Summary

EBUS-TBNA specimen are used for lung cancer diagnosing and staging, as well for molecular analysis. The purpose of this study is to evaluate if samples from on lymph node site can be divided for diagnosis and molecular analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

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

February 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

1.1 years

First QC Date

June 1, 2014

Last Update Submit

October 24, 2016

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and Specificity of lung cancer diagnosis

    We aim to evaluate if splitting the obtained specimen will have an impact on lung cancer diagnosis performed by histopathologic analysis

    6 month

Secondary Outcomes (1)

  • Percentage of successful performed molecular RNA based analysis

    3 month

Eligibility Criteria

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

Subjects suspected to have lung cancer and enlarged mediastinal lymph nodes

You may qualify if:

  • clinical diagnosis of lung cancer
  • enlarged mediastinal or hilar lymph nodes (\>10 mm)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruhrlandklinik-UK Essen

Essen, Germany

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physician Interventional Pneumology

Study Record Dates

First Submitted

June 1, 2014

First Posted

June 5, 2014

Study Start

February 1, 2013

Primary Completion

March 1, 2014

Study Completion

May 1, 2015

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

DE(1)