Analysis of Metabonomics for Pleural Effusion

Metabonomics for Distinguishing Between Benign and Malignant Pleural Effusion and Assessing the Prognosis of Lung Cancer Patients With Malignant Pleural Effusion

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.

Study Overview

• Status: Completed
• Conditions: Pleural Diseases
• Intervention / Treatment: Other: Detection of pleural effusion

Detailed Description

Pleural effusion (PE) is a common yet challenging problem in clinical settings. PE is a symptom caused by over 50 diseases and is typically classified as either malignant pleural effusion (MPE) or benign pleural effusion (BPE). MPE affects a significant number of individuals, with an estimated annual incidence of 500-700 cases per million population. Metastatic cancer is the leading cause of MPE, and lung cancer accounts for approximately 37.5% of cases. The management of MPE is a major clinical challenge due to its association with a typically poor prognosis, with a median survival of only 3 to 12 months. However, predicting survival in MPE patients can be difficult due to significant heterogeneity in underlying malignancy and patient performance status. Therefore, accurate prognostication remains a significant challenge in the management of MPE.

Metabonomics is an analytical technique for detecting metabolites in biological samples and has been widely used in disease diagnosis and prognosis evaluation in recent years. The aim of this study is to use Metabonomics technology to compare and analyze the differences in metabolites between benign and malignant pleural effusion, and to explore its application in the prognosis evaluation of lung cancer patients with malignant pleural effusion.

• Study Type: Observational
• Enrollment (Actual): 300

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

patients with pleural effusion

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
benign pleural effusion; Patients with benign pleural effusion.	Other: Detection of pleural effusion; 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; 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; Detection of pleural effusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predicting one-year survival prognosis in patients with malignant pleural effusion	Number of Patients with malignant pleural effusion followed up for 1 year after diagnosis to collect survival information.	1 year

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Estimated): June 16, 2023

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Effusion; Pleural Diseases
• Other Study ID Numbers: XHJY20230508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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