Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Endobronchial Ultrasound-Guided Transbronchial Needle-Aspiration With Suction in Obtaining Samples From Patients With Suspected Nodal Metastatic Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04116970
Recruitment Status : Not yet recruiting
First Posted : October 7, 2019
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Peter Kneuertz, Ohio State University Comprehensive Cancer Center

Brief Summary:
This trial studies how well endobronchial ultrasound-guided transbronchial needle-aspiration (EBUS-TBNA) with suction works in obtaining samples from patients with suspected lung cancer that has spread to the nodal. EBUS-TBNA samples obtained with additional suction may help to improve material-amounts and decrease blood contamination in the samples.

Condition or disease Intervention/treatment Phase
Lung Carcinoma Procedure: Bronchoscopy Procedure: Ultrasound-Guided Transbronchial Needle Aspiration Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate if suction applied with a vacuum syringe during EBUS-TBNA sampling helps to obtain more material for molecular analyses.

OUTLINE:

Patients undergo bronchoscopy with EBUS-TBUA first without and then with applied vacuum.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Trial to Analyze Endobronchial Ultrasound-Guided Transbronchial Needle-Aspiration (EBUS-TBNA) Samples Obtained With and Without Suction
Estimated Study Start Date : December 31, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Diagnostic (bronchoscopy with EBUS-TBNA with/without vacuum)
Patients undergo bronchoscopy with EBUS-TBUA first without and then with applied vacuum.
Procedure: Bronchoscopy
Undergo bronchoscopy with EBUS-TBNA

Procedure: Ultrasound-Guided Transbronchial Needle Aspiration
Undergo bronchoscopy with EBUS-TBNA
Other Names:
  • EBUS-TBNA
  • Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration




Primary Outcome Measures :
  1. Number of samples collected via endobronchial ultrasound-guided transbronchial needle-aspiration with suction [ Time Frame: Up to 3 years ]
    The qualitative data will have a set number of variable to follow and will be converted to quantitative data. Data will be analyzed using Microsoft Excel, SAS, or SPSS. After checking the normality of the data, all non-parametric data will be converted to parametric data. Appropriate tests for categorical and continuous data will be used. Categorical variables will be compared using Chi-square or Fisher?s Exact test. Normally distributed variables will be compared using Student-T-test and one way analysis of variance. Non-parametric test will include Mann Whitney U test and Kruskal Wallis test. A two tailed p value of < 0.05 will be considered significant.Sample weight (microgram) and visual blood contamination score (0 = no visible blood, 1 = light red shading, 2 = red shading) of endobronchial needle aspiration biopsies obtained with and without suction.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Computed tomography (CT)-scan finding suspicious for lung cancer with nodal metastases
  • Clinically stable to undergo diagnostic workup by bronchoscopy with endobronchial ultrasound

Exclusion Criteria:

  • Pregnant female
  • Minors
  • Prisoners
  • Patients with contraindication for EBUS such as non-reversible anticoagulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04116970


Contacts
Layout table for location contacts
Contact: The Ohio State University Comprehensive Cancer Center 1-800-293-5066 OSUCCCClinicaltrials@osumc.edu

Locations
Layout table for location information
United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Contact: Peter J. Kneuertz, MD    614-685-9922    Peter.Kneuertz@osumc.edu   
Principal Investigator: Peter J. Kneuertz, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Peter Kneuertz, MD Ohio State University Comprehensive Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: Peter Kneuertz, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04116970    
Other Study ID Numbers: OSU-18164
NCI-2018-02965 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
OSU-18164 ( Other Identifier: Ohio State University Comprehensive Cancer Center )
P30CA016058 ( U.S. NIH Grant/Contract )
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases