NCT03270670

Brief Summary

The purpose of this study is to test whether the 19-gauge needle can collect more tissue and get better sampling during a bronchoscopy procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

2 active sites

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 21, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 31, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

August 31, 2017

Last Update Submit

September 6, 2019

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Molecular marker test

    Descriptive statistics will be used to calculate the success rate of the procedure in successful performance of molecular marker testing

    Day of Procedure

Eligibility Criteria

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

Subjects undergoing a standard of care bronchoscopy to determine lung cancer.

You may qualify if:

  • Subjects with known or suspected lung cancer with mediastinal adenopathy as defined by a mediastinal lymph node \>0.5 cm in short axis on EBUS or any lymph node with uptake on FDG-PET scan that is higher than background PET activity.
  • Participants must lack bleeding disorders

You may not qualify if:

  • Subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
  • Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary)
  • Subjects on anticoagulation (other than Aspirin) whom cannot have their anticoagulation held for the procedure due to other clinical reasons (i.e. recent cardiac stent placement).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

Duke Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Momen Wahidi, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 1, 2017

Study Start

August 21, 2017

Primary Completion

January 30, 2019

Study Completion

January 30, 2019

Last Updated

September 10, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)