Longitudinal Follow up of Patients With Pleural Effusion

Longitudinal Follow up of Patients With Pleural Effusion in South Korea

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.

Study Overview

• Status: Recruiting
• Conditions: Pleural Effusion, Malignant; Prognosis

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Yeon Wook Kim, Professor; Phone Number: 82-10-7497-5586; Email: kimyw@snu.ac.kr

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Yeon Wook Kim, Professor; Phone Number: 82-10-7497-5586; Email: kimyw@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who presented with pleural effusion and undergo diagnostic/therapeutic thoracentesis

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality	From date of diagnosis of malignant pleural effusion until the date of death, assessed up to 36 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Yeon Wook Kim, Professor, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 13, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion
• Other Study ID Numbers: B-2006/618-311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No