NCT04735302

Brief Summary

Background: This study aimed to investigate the diagnostic value of thoracic computerized tomography (CT) which is a noninvasive method making the diagnosis of sarcoidosis. Material-Method: The data of 816 patients who received endobronchial ultrasonography (EBUS) for mediastinal lymph node sampling and were subjected to other methods were retrospectively analyzed. 192 patients (sarcoidosis: 62, non-sarcoidosis) were included in the study. The thoracic CT findings of the patients were compared in terms of mediastinal lymph node and pulmonary parenchymal involvement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

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

Study Start

First participant enrolled

February 11, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
Last Updated

February 3, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

January 22, 2021

Last Update Submit

January 31, 2021

Conditions

Keywords

sarcoidosislymh nodesThorax tomography

Outcome Measures

Primary Outcomes (1)

  • Assesment of biopsy necessay

    Diagnosis of sarcoidosis without lymph node biopsy by Thorax computed tomography

    11.012019-22.01.2021

Study Arms (2)

Sarcoidosis, Nonsarcoidosis

Other: Radiographic Feature

Malign, benign

Other: Radiographic Feature

Interventions

Radiographic rewiev

Malign, benignSarcoidosis, Nonsarcoidosis

Eligibility Criteria

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

The study was planned by retrospectively analyzing the data of patients who received EBUS for sampling mediastinal lymph nodes and were subjected to other diagnostic methods such as mediastinoscopy and thoracotomy in the case of non-diagnostic results of EBUS at the Department of Pulmonology at the Faculty of Medicine at KTÜ between 1 January 2013 and 1 July 2019

You may qualify if:

  • \- The patients who received EBUS for sampling mediastinal lymph nodes and were subjected to other diagnostic methods such as mediastinoscopy and thoracotomy in the case of non-diagnostic results of EBUS at the Department of Pulmonology at the Faculty of Medicine at KTÜ

You may not qualify if:

  • The patients whose computerized thoracic tomography images at first admission were not available in the archives of our hospital were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department Of Chest Diseases, School Of medicine, Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 22, 2021

First Posted

February 3, 2021

Study Start

February 11, 2019

Primary Completion

August 1, 2019

Study Completion

January 22, 2021

Last Updated

February 3, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations