NCT01332240

Brief Summary

As the use of endoscopic ultrasonography for mediastinal diagnosis and/or staging is widely spread in Belgium, the investigators aimed to determine the number of mediastinoscopies needed to detect one additional mediastinal lymph node invasion during routine clinical practice in the staging of potentially resectable clinical stage III non-small cell lung cancer.

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
255

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

18 active sites

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

April 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 19, 2011

Status Verified

April 1, 2011

Enrollment Period

2 years

First QC Date

April 5, 2011

Last Update Submit

October 18, 2011

Conditions

Stage III Lung Cancer

Keywords

stagingendosonographylung cancerstage III

Outcome Measures

Primary Outcomes (1)

  • The number of mediastinoscopies needed to detect one additional N2/3

    Efficacy

    1 month

Secondary Outcomes (1)

  • The number of mediastinal lymph nodes stations sampled with endosonography

    1 month

Study Arms (1)

Endosonography

EXPERIMENTAL

Endoscopic ultrasonography (EBUS-TBNA +/- EUS-FNA) for invasive mediastinal nodal staging

Procedure: Endoscopic ultrasonography

Interventions

Endoscopic ultrasonographyPROCEDURE

in order to stage the mediastinum

Endosonography

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients with (suspected) NSCLC in whom invasive mediastinal staging is required based on presence of ACCP group B mediastinal lymph nodes and/or FDG-PET positive (visual interpretation of FDG uptake in mediastinal nodes as present) mediastinal lymph nodes (either ACCP group B or ACCP group D) in lymph node stations 2, 4, 7, 8 or 9 (see Appendix).
  • Potentially operable and resectable disease.
  • Radically treated previous extrathoracic malignancies are allowed whenever the extrathoracic malignancy is considered in remission, and a primary parenchymal lung tumour is present.
  • Provision of a written informed consent.

You may not qualify if:

  • Previous cervical mediastinoscopy.
  • Uncorrected coagulopathy.
  • Former treatment for a lung cancer.
  • Patient unable to give a written informed consent.
  • Absence of a primary parenchymal lung tumour.
  • Distant metastases (cM1 disease) after routine clinical work-up.
  • Clinical N2/3 disease only based on suspected mediastinal lymph nodes in stations 5 or 6.
  • Patients belonging to ACCP groups A and C based on CT scan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Onze Lieve Vrouw Ziekenhuis

Aalst, Belgium

WITHDRAWN

Middelheim Ziekenhuis

Antwerp, Belgium

RECRUITING

Imelda ziekenhuis

Bonheiden, Belgium

RECRUITING

Sint-Jan Ziekenhuis Brugge

Bruges, Belgium

RECRUITING

Hopital Erasme Brussels

Brussels, Belgium

RECRUITING

Centre Hospitalier Universitaire de Charleroi

Charleroi, Belgium

RECRUITING

AZ Monica

Deurne, Belgium

RECRUITING

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

RECRUITING

Jesse Ziekenhuis

Hasselt, Belgium

RECRUITING

Univeristair Ziekenhuis Brussel

Jette, Belgium

RECRUITING

Center Hospitalier Jolimont

La Louvière, Belgium

RECRUITING

UCL

Mont-Godinne, Belgium

WITHDRAWN

Hopital Sainte-Elisabeth

Namur, Belgium

RECRUITING

Mariaziekenhuis

Overpelt, Belgium

RECRUITING

Heilig Hart Ziekenhuis

Roeselare, Belgium

RECRUITING

Sint-Elisabeth en Sint-Jozef ziekenhuis

Turnhout, Belgium

RECRUITING

Sint-Augustinus ziekenhuis

Wilrijk, Belgium

RECRUITING

UCL Saint-Luc

Woluwe, Belgium

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Christophe Dooms

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Kurt Tournoy

    University Hospital Ghent Belgium

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe Dooms, MD, PhD

CONTACT

0032 16 34.09.49christophe.dooms@uzleuven.be

Kurt Tournoy, MD, PhD

CONTACT

kurt.tournoy@ugent.be

Study Design

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

Study Record Dates

First Submitted

April 5, 2011

First Posted

April 11, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2013

Study Completion

July 1, 2013

Last Updated

October 19, 2011

Record last verified: 2011-04

Locations

BE(18)