NCT04331548

Brief Summary

The aim of this study is to assess the findings of mediastinal/hilar LN sampling by EBUS-TBNA in patients with non-sarcoidosis interstitial lung disease ( ILD) who demonstrate LN enlargement on chest imaging. Patients with non-sarcoidosis ILD referred for bronchoscopy will undergo LN sampling by EBUS-TBNA. Cytology results will be recorded along with clinico-radiologic features, BAL findings, histology and final ILD diagnosis.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 22, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 30, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

3.7 years

First QC Date

March 22, 2020

Last Update Submit

May 9, 2022

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

  • assessing the findings of mediastinal/hilar LN sampling by EBUS-TBNA in patients with non-sarcoidosis ILD who demonstrate LN enlargement on chest imaging.

    during the procedure/surgery

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients referred for bronchoscopy (BAL, TBLB or TBCB) in the Interventional Pulmonology Unit at Sheba Medical Center

You may qualify if:

  • non-sarcoidosis ILD (low probably of sarcoidosis based on radiology),
  • referred for bronchoscopy (BAL, TBLB or TBCB) in the Interventional Pulmonology Unit at Sheba Medical Center
  • Patients with LN enlargement ≥1 cm in short diameter at stations 2, 4, 7, 10 or 11 (LN stations accessible to EBUS-TBNA)

You may not qualify if:

  • known ILD
  • ILD with no indication to bronchoscopy
  • contraindication to bronchoscopy .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2020

First Posted

April 2, 2020

Study Start

May 30, 2020

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

May 10, 2022

Record last verified: 2022-05

Locations

IL(1)