NCT05759117

Brief Summary

Having a pleural effusion is a common reason for being hospitalized, as it usually requires in-patient care for invasive diagnostic and therapeutic procedures. Specific subtypes of pleural effusion may warrant recurrent admissions, a longer hospital stay and consume more healthcare resources. Despite the recent advancement of pleural medicine, better research is increasingly desired to fill the gaps in establishing an early diagnosis and optimal management of pleural effusion from various causes. Local data on different aspects of pleural effusion is also lacking.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

3.6 years

First QC Date

February 25, 2023

Last Update Submit

August 29, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Aetiology of pleural effusion

    spectrum of aetiology for pleural effusion

    1 month

Secondary Outcomes (2)

  • Management of pleural effusion

    1 month

  • Prognosis of pleural effusion

    1 month

Study Arms (1)

Pleural effusion

All patients with pleural effusion who will undergo thoracentesis

Procedure: thoracentesis

Interventions

thoracentesisPROCEDURE

A type of pleural procedure that will yield pleural fluid for subsequent analysis

Also known as: chest drain insertion
Pleural effusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have pleural effusion and will undergo thoracentesis for pleural fluid sampling

You may qualify if:

  • Patients hospitalized for pleural effusion.
  • Pleural tapping will be performed for pleural fluid analysis.
  • Aged 18 years old or above

You may not qualify if:

  • \- Failed to obtain informed consent due to the patient's refusal or cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

40mL pleural fluid will be collected during thoracentesis or pleural drain insertion, or from collecting bags. The research pleural fluid will be transferred on ice and stored at - 80oC until assay for subsequent approved studies. 6mL blood will be collected. The blood will be centrifuged, and the supernatant will be stored at - 80oC until assay for subsequent approved studies.

MeSH Terms

Conditions

Pleural Effusion

Interventions

Thoracentesis

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ParacentesisSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • David SC Hui, MD

    Chinese University of Hong Kong

    STUDY DIRECTOR

Central Study Contacts

Ka Pang Chan, MBChB

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Lecturer

Study Record Dates

First Submitted

February 25, 2023

First Posted

March 8, 2023

Study Start

September 1, 2022

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations