Longitudinal Follow up of Patients With Pleural Effusion

Prognosis Clinical Trial

Official title:

Longitudinal Follow up of Patients With Pleural Effusion in South Korea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04670562
• Other study ID #: B-2006/618-311
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2022
• Source: Seoul National University Bundang Hospital
• Contact: Yeon Wook Kim, Professor
• Phone: 82-10-7497-5586
• Email: kimyw[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study aims to evaluate the clinical course of patients diagnosed with pleural effusion and determine various clinical factors and biomarkers associated that can predict the diagnosis and clinical outcome and prognosis of patients with pleural effusion due to specific causes.

Description:

Patients who presented to Seoul National University Bundang Hospital with pleural effusion would be recruited. Pleural fluid and blood samples would be collected. All patients will receive routine diagnostic procedures and medical care and treatments according to the diagnosis; the original cancer if diagnosed with malignant effusion, and managements for pleural effusion control. Patients would be observed for the clinical course and prognosis up to 3 years without any interventions caused by this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients presented with pleural effusion

• Patients who undergo thoracentesis and fluid analysis for diagnosis and management

Exclusion Criteria:

• Patients who refuse to be enrolled

Related Conditions & MeSH terms

• Pleural Effusion
• Pleural Effusion, Malignant
• Prognosis

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality	From date of diagnosis of malignant pleural effusion until the date of death, assessed up to 36 months.
Secondary	Disease progression	Progression of original malignancy or new metastasis occured	From date of diagnosis of malignant pleural effusion until the date of first documented disease progression, assessed up to 36 months.