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

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT06043882
Collaborator
(none)
55
1
6.9
8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: flexible bronchoscopy

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 Design

Study Type:
Observational
Actual Enrollment :
55 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Number of Participants Diagnosed With Sarcoidosis by Bronchoscopic Transbronchial Needle Aspiration After Corona Virus Disease of 2019 Infection.
Actual Study Start Date :
Nov 1, 2022
Actual Primary Completion Date :
Apr 30, 2023
Actual Study Completion Date :
May 30, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hoda atiatullah Cairo Egypt 02

Sponsors and Collaborators

  • Ain Shams University

Investigators

  • Principal Investigator: Hoda A Mohamed, MD, faculty of medicine, Ain Shams university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ain Shams University
ClinicalTrials.gov Identifier:
NCT06043882
Other Study ID Numbers:
  • FMASU-R 151/2022
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 22, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ain Shams University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2023