Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance

NCT07882758 · tracked via the Priya Life Science China tracker

Sponsor

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

Phase

Observational

Started

2026-10-01

Last updated

2026-10-27

Condition(s) studied

Malignant Pleural Effusions (Mpe)Lung Cancer (Diagnosis)

Study summary

Lung cancer is the malignant tumor with the highest incidence and mortality rates in China. Malignant pleural effusion (MPE) is one of its most common complications, affecting approximately 15%-50% of patients with non-small cell lung cancer at initial diagnosis or during disease progression and indicating advanced-stage disease with a median survival of only 3-12 months. This study aims to establish the first large-scale, multicenter LC-MPE disease-specific cohort, integrating clinical, imaging, pleural fluid laboratory, pathological and genomic multimodal data to develop an AI-assisted model for the differential diagnosis of benign versus malignant MPE and a prognostic prediction model for LC-MPE patients. The study comprises a retrospective phase (3,000 patients diagnosed between January 2022 and September 2026) and a prospective phase (200 patients diagnosed between October 2026 and October 2028). The primary endpoint is overall survival (OS); secondary endpoints include pleural effusion progression-free survival (PE-PFS), duration of pleural effusion control, and 60-day and 30-day MPE recurrence rates. This observational study does not interfere with routine clinical care and strictly protects the personal information of participants.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age 18 years or older; gender not restricted. * Malignant pleural effusion of lung cancer origin. * Diagnosis confirmed by positive pleural fluid cytology, pleural biopsy, or clinical/imaging comprehensive assessment. Exclusion Criteria: * Pleural effusion caused by secondary lung cancer (metastasis to the lung from tumors at other sites). * Concurrent presence of other primary malignant tumors. * Severe lack of critical clinical, imaging, or laboratory data. * Death within 30 days after diagnosis of malignant pleural effusion. * Mental disorders that prevent cooperation with follow-up.

Primary outcome measure(s)

Overall Survival (OS) — From date of diagnosis of malignant pleural effusion to death from any cause, or end of study (up to 24 months)
Overall survival (OS) is defined as the time from the date of diagnosis of malignant pleural effusion (MPE) to death from any cause. Patients who are alive or lost to follow-up at the end of the study will be censored at the last known alive date. OS will be compared among different treatment groups using Kaplan-Meier methods and Cox regression analysis.

Trial sites (1)

Facility	City	Region	Status
Union hospital, Tongji Medical college, Huazhong University of Science and Technology	Wuhan	Hubei

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07882758 on ClinicalTrials.gov ↗ ← All trials in China