NCT01456429

Brief Summary

This is a prospective non-randomized multicenter clinical trial performing endobronchial and esophageal ultrasound for mediastinal lymph node staging of operable and resectable cT1-T2-selectedT3 cN1 cM0 NSCLC.

Trial Health

58
Monitor

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 not_applicable nonsmall-cell-lung-cancer

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable nonsmall-cell-lung-cancer

Geographic Reach
2 countries

3 active sites

Status
active not recruiting

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, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2011

Completed
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

15.8 years

First QC Date

October 18, 2011

Last Update Submit

July 12, 2024

Conditions

Non-small Cell Lung Cancer

Keywords

invasive stagingmediastinal lymph nodesendosonographysurgical staginglung cancer

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC

    One month

Secondary Outcomes (2)

  • NPV of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC

    one month

  • Cost-effectiveness analysis for echo-endoscopy in cN1 disease NSCLC

    one month

Study Arms (1)

Thoracic endosonography

EXPERIMENTAL

Endobronchial-ultrasound controlled transbronchial needle aspiration (EBUS-TBNA) in combination with a transoesophageal-ultrasound controlled needle aspiration of mediastinal lymph nodes

Procedure: Thoracic endosonography

Interventions

Thoracic endosonographyPROCEDURE

Endobronchial-ultrasound controlled transbronchial needle aspiration (EBUS-TBNA) in combination with a transoesophageal-ultrasound controlled needle aspiration of mediastinal lymph nodes

Also known as: thoracic echo-endoscopy
Thoracic endosonography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with operable and resectable (suspected) NSCLC
  • Patients with clinical N1 staging based on PET/CT
  • Only T1, T2, and selected T3 (i.e. intraparenchymal tumour \>7cm, chest wall, or additional nodule in the same lobe) are allowed.

You may not qualify if:

  • Patients with enlarged mediastinal lymph nodes on chest CT or FDG-PET positive mediastinal lymph nodes
  • Patients with a central tumour staged T3 or any T4.
  • All stage IV patients.
  • Patient unable to give informed consent.
  • Patient previously underwent a mediastinoscopy.
  • Tracheal or upper airway stenosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Universitaire Ziekenhuizen leuven

Leuven, 3000, Belgium

Location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500, Netherlands

Location

Related Publications (1)

  • Dooms C, Tournoy KG, Schuurbiers O, Decaluwe H, De Ryck F, Verhagen A, Beelen R, van der Heijden E, De Leyn P. Endosonography for mediastinal nodal staging of clinical N1 non-small cell lung cancer: a prospective multicenter study. Chest. 2015 Jan;147(1):209-215. doi: 10.1378/chest.14-0534.

    PMID: 25211526DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Christophe Dooms

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Kurt Tournoy

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2011

First Posted

October 20, 2011

Study Start

January 1, 2010

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

July 15, 2024

Record last verified: 2024-07

Locations

BE(2)NL(1)