The Diagnosis and Mechanism of Pleural Effusion | NCT03997669

Studies
The Diagnosis and Mechanism of Pleural Effusion

NCT03997669

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Status

Completed

Last Update Posted

Nov 16, 2021Actual

Enrollment

2,000Actual

Phase

Not provided

Conditions

Pleural Diseases

Interventions

Collection of pleural effusion

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2019Actual

Primary Completion Date

Feb 1, 2020Actual

Completion Date

Oct 1, 2021Actual

First Submitted Date

Jan 22, 2019

First Submission Date that Met QC Criteria

Jun 22, 2019

First Posted Date

Jun 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2021

Last Update Posted Date

Nov 16, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yang Jin, Professor, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The diagnosis, treatment and mechanism of pleural diseases

Detailed Description

The diagnosis and treatment of benign and malignant pleural effusions, the mechanisms of pleural diseases

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental group		patients with malignant pleural effusion	Other: Collection of pleural effusion
control group		patients with benign pleural effusion	Other: Collection of pleural effusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collection of pleural effusion	Other	Detection of pleural effusion	control group experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival	the percentage of people in a group who are alive after a year for malignant pleural effusion	1 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with pleural effusion, who has not been treated

Exclusion Criteria:

Patients with pleural effusion, who has already been treated

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients with pleural effusion

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jinshuo Fan, MD	Key Laboratory of Respiratory Diseases of the Ministry of Health	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jinshuo Fan		Wuhan	State...	430022	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided