NCT05906823

Brief Summary

This is a multicenter retrospective study that collected diagnostic information of patients with pleural effusion. The overall survival (OS) time of malignant patients was followed up, defined as the time from diagnosis to death. Clinical data and residual pleural effusion specimens were collected from patients. Metabonomics was utilized to differentiate between benign and malignant pleural effusion and to evaluate the prognosis of lung cancer patients with malignant pleural effusion.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

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

January 1, 2016

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

7 years

First QC Date

May 8, 2023

Last Update Submit

June 15, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Metabolomic detection of pleural effusion to distinguish between benign and malignant pleural effusion

    The concentration of metabolites in the sample of pleural effusion of benign and malignant pleural effusion patients.

    Within two weeks of detection of a pleural effusion

Secondary Outcomes (1)

  • Predicting one-year survival prognosis in patients with malignant pleural effusion

    1 year

Study Arms (3)

benign pleural effusion

Patients with benign pleural effusion.

Other: Detection of pleural effusion

malignant pleural effusion patients with bad prognosis

The OS time of malignant pleural effusion patients is\<1 year.

Other: Detection of pleural effusion

malignant pleural effusion patients with good prognosis

The OS time of malignant pleural effusion patients is ≥1 year.

Other: Detection of pleural effusion

Interventions

Detection of pleural effusion

benign pleural effusionmalignant pleural effusion patients with bad prognosismalignant pleural effusion patients with good prognosis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with pleural effusion

You may qualify if:

  • Years to 80 Years; detection of pleural effusion by chest computed tomography, radiography, or ultrasonography; pathologically confirmed lung cancer in pleural effusion.

You may not qualify if:

  • pleural effusion not caused by lung cancer or of unknown origin; other concurrent malignant diseases; incomplete information; lack of any follow-up data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

pleural effusion

MeSH Terms

Conditions

Pleural Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 8, 2023

First Posted

June 18, 2023

Study Start

January 1, 2016

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share