Using Pleural Effusions to Diagnose Cancer

NCT03319472 | Completed

• 1 other identifier: 22699/21.11.2013
• Study Type: observational
• Target: 439
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusion

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Diagnosis of Malignancy

  Cytologic or histologic evidence of malignant cells or tissues in the pleural space.

  One month post-admission

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to a tertiary hospital with a pleural effusion.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

Patras University Hospital

Rio, Achaia, 26504, Greece

Location

Biospecimen

Retention: SAMPLES WITH DNA

Pleural fluid will be centrifuged and cells will be separated from supernatants. The latter will be stored together with matched serum samples at -80 degrees C. Cell pellets will be stored in DMEM 10% FBS, 2 % DMSO at the same temperature.

MeSH Terms

Conditions

Pleural Effusion; Neoplasms; Fasting

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Feeding Behavior; Behavior

Study Officials

• Georgios T Stathopoulos, MD, PhD

  Associate Professor of Physiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physiology

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 24, 2017
• Study Start: November 21, 2013
• Primary Completion: November 21, 2017
• Study Completion: November 21, 2018
• Last Updated: December 10, 2019

Record last verified: 2019-12

Locations

GR (1)