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NCT07882758
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Conditions: Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 3000
Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Location: Union hospital, Tongji Medical college, Huazhong University of Science and Technology Wuhan Hubei
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07882758). StuddyBuddy aggregates publicly available trial information.