Using Pleural Effusions to Diagnose Cancer

NCT ID: NCT03319472

Last Updated: 2019-12-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 439 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-21
• Study Completion Date: 2018-11-21

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.

Conditions

Pleural Effusion

Keywords

malignant; cancer; simple bedside test; rapid; score; widely available; feasible

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Benign Pleural Effusion

Patients that will be diagnosed within a month from admission with any non-malignant cause of pleural effusion, including but not limited to effusions caused by common or tuberculous or fungal infection, heart failure, etc. Documentation of the etiology will be required for inclusion in this group, including but not limited to bacteriology, virology, PCR, radiology, heart echocardiogram or catheterization, as appropriate.

No interventions assigned to this group

Malignant Pleural Effusion

Patients that will be diagnosed within a month from admission with any malignant cause of pleural effusion, including but not limited to effusions caused by lung, breast, colon, ovary, mesothelial, hematopoietic, prostate, or any other cancer. Diagnosis will be based on verification of the presence of malignant cells in the pleural fluid or tissues. Patients with cancer and an effusion without such documentation will be assigned to the benign group if an alternative diagnosis is made. In any other case, they will be excluded.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Patras

OTHER

Sponsor Role: lead

Responsible Party

Georgios Stathopoulos

Associate Professor of Physiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georgios T Stathopoulos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Physiology

Locations

Patras University Hospital

Rio, Achaia, Greece

Countries

Greece

Other Identifiers

22699/21.11.2013

Identifier Type: -

Identifier Source: org_study_id