NCT04670562

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

December 9, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 22, 2022

Status Verified

April 1, 2022

Enrollment Period

3.8 years

First QC Date

December 9, 2020

Last Update Submit

June 20, 2022

Conditions

Pleural Effusion, MalignantPrognosis

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality

    From date of diagnosis of malignant pleural effusion until the date of death, assessed up to 36 months.

Secondary Outcomes (1)

  • Disease progression

    From date of diagnosis of malignant pleural effusion until the date of first documented disease progression, assessed up to 36 months.

Eligibility Criteria

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

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

You may qualify if:

  • Patients presented with pleural effusion
  • Patients who undergo thoracentesis and fluid analysis for diagnosis and management

You may not qualify if:

  • Patients who refuse to be enrolled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Pleural fluid samples and blood samples will be collected from each participants.

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract Diseases

Study Officials

  • Yeon Wook Kim, Professor

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeon Wook Kim, Professor

CONTACT

82-10-7497-5586kimyw@snu.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2020

First Posted

December 17, 2020

Study Start

March 1, 2021

Primary Completion

December 1, 2024

Study Completion

December 31, 2025

Last Updated

June 22, 2022

Record last verified: 2022-04

Locations

KR(1)