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

StatusNot Yet Recruiting
PhaseNot specified
Started

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Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07882758
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborators: Henan Provincial People's Hospital, Xiangyang Central Hospital, Hubei University of Medicine, Zhongnan Hospital, Taihe Hospital, First People's Hospital of Xianyang, Renmin Hospital of Wuhan University, The First Affiliated Hospital of Guangzhou Medical University, Wuhan Central Hospital, Central Hospital of Xiaogan, Yichang Central People's Hospital
Conditions
(from sponsor)
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
Related terms Disease, Lung Neoplasms, Myeloproliferative Disorder, Chronic, with Eosinophilia, Pleural Effusion, Malignant
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov