NCT02009319

Brief Summary

The aim of this pilot study is to evaluate EBUS elastography strain ratio in assessment of mediastinal lymph nodes in patients with suspicion for lung cancer for the first time. Strain ratios of mediastinal lymph nodes will be compared with EBUS B-mode features and with tissue diagnosis as a gold standard.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2013

Shorter than P25 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

August 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

September 10, 2015

Status Verified

September 1, 2015

Enrollment Period

7 months

First QC Date

December 4, 2013

Last Update Submit

September 8, 2015

Conditions

Lung Cancer

Keywords

endobronchial ultrasoundEBUS - TBNAelastographystrain ratiolung cancer staging

Outcome Measures

Primary Outcomes (1)

  • elastography strain ratio

    Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV)

    up to 7 months

Eligibility Criteria

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

Consecutive patients at least 18 years old, referred to bronchoscopy with suspicion for lung cancer according to chest CT-scan

You may qualify if:

  • enlarged discrete N2/N3 lymph nodes
  • central tumor with normal mediastinal lymph nodes
  • enlarged N1 lymph nodes with normal mediastinal lymph nodes

You may not qualify if:

  • metastatic disease
  • severe co-morbidity that disqualified surgical treatment
  • mediastinal infiltration by tumor
  • small peripheral lung tumor with normal-sized mediastinal lymph nodes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic of Pulmonary and Allergic Diseases Golnik

Golnik, Golnik, 4204, Slovenia

Location

Biospecimen

Retention: SAMPLES WITH DNA

EBUS TBNA lymph node specimen - a part of routine diagnostic procedure

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
MD, specialist from pulmonary diseases

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 12, 2013

Study Start

August 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

September 10, 2015

Record last verified: 2015-09

Locations

SL(1)