Clinical trial NCT03319472: Using Pleural Effusions to Diagnose Cancer
Official title: Clinical Identification of Malignant Pleural Effusions in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleural Effusion
Keywords: malignant
cancer
simple bedside test
rapid
score
widely available
feasible
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to a tertiary hospital with a pleural effusion.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnosis of Malignancy
timeFrame: One month post-admission
Secondary outcomes:
Other outcomes:
Locations:
city: Rio
country: Greece
facility: Patras University Hospital
state: Achaia
Study officials:
affiliation: Associate Professor of Physiology
name: Georgios T Stathopoulos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: