NCT03260088

Brief Summary

Pleural effusion is an accumulation of fluid between the tissue layers that line the lungs and chest cavity. It has an estimated prevalence of 320 per 100,000 people in industrialized countries. The cause of the pleural effusion remains unclear in a substantial percentage of patients with persistently exudative effusions.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

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

August 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 30, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

August 17, 2017

Last Update Submit

August 23, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • diagnosis new causes of previously remained undiagnosed cases of pleural effusion by using IgG4 in Assiut university hospital

    Immunoglobulin G4 will be puified from pleural fluids by diethylaminoetyyl cellulose ion exchange nephlometry in patients with undiagnosed effusion after common investigations as it positive in IgG4 related disease. The median effusion IgG4 level was 41mg/dl in the IgG4 positive group and 27mg/dl in the IgG negative group.

    one year

Study Arms (1)

patients with pleural effusion

In patients with pleural effusion that remains undiagnosed with common diagnostic algorithm, immunoglobulin G4 will be done in pleural fluid

Diagnostic Test: Immunoglobulin G4

Interventions

Immunoglobulin G4DIAGNOSTIC_TEST

IgG4 will be purified from pleural fluids by diethylaminoethyl (DEAE)-cellulose ion exchange nephlometry

patients with pleural effusion

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with exudative pleural effusion admitted to Assiut university hospital in period of October 2017 to October 2018

You may qualify if:

  • All patients with exudative pleural effusion admitted to Assiut university hospital in period of October 2017 to October 2018

You may not qualify if:

  • Patients with transudative pleural effusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Della-Torre E, Lanzillotta M, Doglioni C. Immunology of IgG4-related disease. Clin Exp Immunol. 2015 Aug;181(2):191-206. doi: 10.1111/cei.12641. Epub 2015 Jun 8.

    PMID: 25865251BACKGROUND
  • Davies HE, Nicholson JE, Rahman NM, Wilkinson EM, Davies RJ, Lee YC. Outcome of patients with nonspecific pleuritis/fibrosis on thoracoscopic pleural biopsies. Eur J Cardiothorac Surg. 2010 Oct;38(4):472-7. doi: 10.1016/j.ejcts.2010.01.057. Epub 2010 Mar 12.

    PMID: 20219385BACKGROUND
  • Ferrer JS, Munoz XG, Orriols RM, Light RW, Morell FB. Evolution of idiopathic pleural effusion: a prospective, long-term follow-up study. Chest. 1996 Jun;109(6):1508-13. doi: 10.1378/chest.109.6.1508.

    PMID: 8769502BACKGROUND

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Raafat T Elsokary, Prof

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Raafat T Elsokary, Prof

CONTACT

Ahmed Metwally, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 24, 2017

Study Start

October 30, 2017

Primary Completion

October 30, 2019

Study Completion

January 30, 2020

Last Updated

August 24, 2017

Record last verified: 2017-08