Number of Participants Diagnosed With Sarcoidosis by Bronchoscopic Transbronchial Needle Aspiration After COVID- 2019 .

September 21, 2023 updated by: Ain Shams University

Number of Participants Diagnosed With Sarcoidosis by Bronchoscopic Transbronchial Needle Aspiration After Corona Virus Disease of 2019 Infection.

The goal of this observational study is to learn about sarcoidosis development after COVID-19 infection.

The main question it aims to answer is:

  • prevalence of Sarcoidosis among patients previously infected with COVID-19.

Participants will:

  • provide previous positive RT-PCR for COVID-19
  • Have computed tomography of the Chest with suggestive findings of sarcoidosis
  • Have bronchoscopic guided biopsies and pathological analysis to detect number of patients with sarcoidosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective cross sectional study was performed on a total of 55 patients with mediastinal and /or hilar lymphadenopathy with or without lung infiltrates referred to Bronchoscopy unit , Chest department, Ain-Shams University hospital for biopsy taking and diagnosis.

All patients were subjected to the following : history taking , clinical examination , radiological assessment by computed tomography (CT )chest , fiberoptic bronchoscopy where biopsies were taken either by conventional-Trans-bronchial needle aspiration (c-TBNA) , endo-bronchial ultrasound (EBUS-TBNA) or direct forceps biopsies and sent for histopathological examination and if the patient had past history of COVID-19 infection with previous positive reverse transcriptase- polymerase chain reaction assay (RT-PCR).

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • Hoda atiatullah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients previously diagnosed as COVID -19 by RT-PCR ,with mediastinal or hilar lymphadenopathy with or without lung infiltrates referred to bronchoscopy unit ,Chest Department, Ain-Shams University Hospital for diagnosis.

Description

Inclusion Criteria:

  • All adult patients with previous positive RT-PCR for COVID -19 and CT chest findings of mediastinal and or hilar lymphadenopathy with or without lung infiltrate will be included. .

Exclusion Criteria:

  • Patients younger than 18 years old Patients
  • Patients refuse to participate in the study
  • Patients previously diagnosed as sarcoidosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
the relation between COVID-19 infection and the development of sarcoidosis .
All patients were subjected to the following : history taking , clinical examination , radiological assessment by CT chest , fiberoptic bronchoscopy where biopsies were taken either by conventional TBNA (c-TBNA) , EBUS-TBNA or direct forceps biopsies and sent for histopathological examination and if the patient had past history of COVID-19 infection with previous positive RT-PCR.
Procedure: flexible bronchoscopy
fiberoptic bronchoscopy was done where biopsies were taken either by conventional TBNA (c-TBNA) , EBUS-TBNA or direct forceps biopsies and sent for histopathological examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and risk factors of sarcoidosis development after COVID -19 infection as diagnosed by TBNA guided tissue biopsies in bronchoscopy unit, chest department, Ain Shams university.
Time Frame: 6 months
Number of COVID-19 patients diagnosed by TBNA guided biopsies as having granulomatous tissue suggesting sarcoidosis development, and risk factors that associate its development.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Hoda A Mohamed, MD, Faculty of Medicine, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

September 17, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU-R 151/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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