Analysis of Metabonomics for Pleural Effusion

Sponsor
Wuhan Union Hospital, China (Other)
Overall Status
Completed
CT.gov ID
NCT05906823
Collaborator
(none)
300
84

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
300 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Metabonomics for Distinguishing Between Benign and Malignant Pleural Effusion and Assessing the Prognosis of Lung Cancer Patients With Malignant Pleural Effusion
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Jan 1, 2023
Actual Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Metabolomic detection of pleural effusion to distinguish between benign and malignant pleural effusion [Within two weeks of detection of a pleural effusion]

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

Secondary Outcome Measures

  1. Predicting one-year survival prognosis in patients with malignant pleural effusion [1 year]

    Number of Patients with malignant pleural effusion followed up for 1 year after diagnosis to collect survival information.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Wuhan Union Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yang Jin, Professor, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier:
NCT05906823
Other Study ID Numbers:
  • XHJY20230508
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2023