Using Pleural Effusions to Diagnose Cancer

Completed

• Conditions: Pleural Effusion

• Registration Number: NCT03319472
• Lead Sponsor: University of Patras

Brief Summary

Pleural effusions (PE) are common conditions that signal either infection or cancer. The investigators aim to develop, validate, and prospectively assess the MAPED score, a clinical score that predicts malignancy at admission. This tool will assist clinicians all over the world to rapidly assess the probability of an effusion being malignant within 4 hours of admission.

Detailed Description

Background: Pleural effusions (PE) are common conditions that signal either pleural-disseminated infection or cancer. While these diagnoses bear tremendous importance for patients, they require invasive procurement of pleural tissues and/or cells and time. Simple and rapid diagnostic markers of pleural malignancy at admission that streamline diagnostic and treatment efforts remain unidentified.

Objective: To develop, validate, and prospectively assess markers of malignancy of PE at admission.

Methods: A prospective cohort of patients with PE from different etiologies will be recruited stating on 11.21.2013 and prospectively ending on 11.21.2023. Data will be collected within 4 hours of admission including history, chest X-ray, and blood and pleural fluid (PF) cell counts and basic biochemistry. Pleural fluid and serum will be biobanked for future analyses. Patients will sign informed consent forms. Diagnosis will be confirmed using standard microbiology, cytology, histology, and imaging techniques. Patients undiagnosed within a month will be excluded. Variables will be entered into binary regression and receiver-operator analyses using malignancy as the target to develop the MAPED score, a clinical score that predicts malignancy at admission. MAPED will be retrospectively validated in separate published cohorts from the first therapeutic interventions in malignant effusion (TIME) 1-3 trials from Oxford UK. Data will be censored and analyzed three times, at 40-month intervals since study initiation.

Study Timeline

• Study Start: 2013-11-21
• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-10-19
• Study First Posted: 2017-10-24
• Primary Completion: 2017-11-21
• Study Completion: 2018-11-21
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-08
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 439

Inclusion Criteria

• Pleural effusion
• Hospital admission
• No previous pleural procedure
• Age > 18 years
• No previous chemoradiotherapy
• No antibiotic therapy during previous trimester
• All history, chest X-ray, and pleural and blood cell counts and biochemistry entry data obtained within 4 hours after admission

Exclusion Criteria

• No diagnosis at one month post-admission
• No informed consent provided
• Age < 18 years
• History, chest X-ray, or pleural and blood cell counts and biochemistry entry data obtained later than 4 hours after admission

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis of Malignancy	One month post-admission	Cytologic or histologic evidence of malignant cells or tissues in the pleural space.

Trial Locations

Locations (1)

Patras University Hospital; 🇬🇷 Rio, Achaia, Greece