NCT00832715

Brief Summary

The goal of this clinical research study is to learn how accurately an endobronchial ultrasound transbronchial needle aspiration (EBUS -TBNA) may detect mediastinal lymph node metastases in patients with clinical stage I and II non-small cell lung cancer (NSCLC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_1 lung-cancer

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_1 lung-cancer

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

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

7.3 years

First QC Date

January 29, 2009

Last Update Submit

July 18, 2016

Conditions

Lung Cancer

Keywords

LungLung CancerNSCLCNon Small Cell Lung CancerSquamous CellAdenocarcinomaLarge CellEndobronchial Ultrasound Transbronchial Needle AspirationMediastinal lymph node negative diseaseMediastinal Nodal MetastasisEBUS-FNAEndobronchial Ultrasound Fine Needle AspirationEBUS guided needle mediastinal lymph node biopsyBiopsyPET scanPositron Emission TomographyCT ScansComputed Tomography ScansLymph nodeMediastinoscopyBronchoscope

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with False Negative Rate Using EBUS Guided Mediastinal Lymph Node Biopsy

    False negative rate estimated using EBUS guided mediastinal lymph node biopsy following a negative positron emission tomography (PET) scan with a 90% credible interval.

    Patient participation 1 hour to complete EBUS-TBNA

Study Arms (1)

EBUS-TBNA

EXPERIMENTAL

Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA)

Procedure: EBUS-TBNA

Interventions

EBUS-TBNAPROCEDURE

Tissue sample collected bronchoscope using needle aspirate of lung lymph gland, procedure takes 1 hour.

Also known as: Endobronchial Ultrasound Transbronchial Needle Aspiration
EBUS-TBNA

Eligibility Criteria

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

You may qualify if:

  • Patient must be \>/= 18 years old.
  • Patient must have Eastern Cooperative Oncology Group (ECOG)/Zubrod status 0-2.
  • Patient must have proven or suspected NSCLC (squamous cell, adenocarcinoma, or large cell) and be clinical Stage I or II, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer (T1-3 N0, T1-2 N1).
  • Patient must be eligible for definitive surgical therapy for primary NSCLC.
  • Patient or the patient's legally acceptable representative must provide written informed consent prior to registration and any study-related procedures.
  • If the patient is a survivor of a prior invasive cancer, all of the following criteria must apply: a. Patient has undergone potentially curative therapy for all prior malignancies. b. No evidence of active / recurrent disease.
  • All females of childbearing age must have a negative pregnancy test before beginning the study.

You may not qualify if:

  • Patient has received prior chemotherapy or radiotherapy for this cancer.
  • Patient is considered a poor risk for surgery due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
  • Patient has contraindication to either endobronchial ultrasound or mediastinoscopy such as: history of bleeding diathesis, latex allergy, mediastinoscopy, mediastinal nodal resection, tracheostomy.
  • Patients malignancy consistent with well differentiated (carcinoid) neuroendocrine histology.
  • Patient has two separate same histology lung tumors (where the question of two separate primaries or metastatic disease makes definitive clinical staging inaccurate).
  • Females who are pregnant and/or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • George A. Eapen, M.D.

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 20, 2016

Record last verified: 2016-07

Locations

US(1)