Serum Biomarkers in Diagnosis of Mesothelioma

Completed

• Conditions: Mesothelioma
• Interventions: Biological: Mesothelin, hyaluronan, osteopontin, syndecan-1

• Registration Number: NCT02029105
• Lead Sponsor: Eskisehir Osmangazi University

Brief Summary

In this study, the investigators analyzed the efficiencies of hyaluronan, osteopontin, C-ERC/mesothelin, N-ERC/mesothelin and syndecan-1 serum levels, both individually and in combination, in distinguishing malignant pleural mesothelioma patients from patients with metastatic malignant pleural diseases, benign pleural diseases, and benign asbestos pleurisy.

Detailed Description

In the year 2002, a database for the pleural diseases was constructed to be prospectively filled in the department. The findings, outcome features and characteristics of follow-up for all cases with pleural diseases have been recorded in this database. The patient data, including epidemiological characteristics, smoking status, history of other diseases and co-morbid conditions, previous asbestos exposure, medications and additional physical and radiological examination findings, including computed tomography scans, both serum and pleural fluid laboratory investigational data and indications of invasive procedures, were recorded in the database mentioned above. The methods employed in the diagnosis of patients; any complications; characteristics such as the stages of diseases, treatments, and course of treatments; and results were also recorded in the database. From the date of the first database establishment, a "tissue, blood, serum, and fluid specimen bank" was constructed; tissue, blood, serum and pleural fluid samples of patients, which had been taken at the beginning of diagnosis process, were stored in this bank at -80°C. The blood, serum, and pleural fluid samples of patients were stored during the diagnosis process, and if conducted, pleural tissue samples taken during invasive procedures were also stocked.

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2010-12
• Study Completion: 2013-10
• Status Verified: 2014-01
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-06
• Last Update Submitted: 2014-01-06
• Study First Posted: 2014-01-07
• Last Update Posted: 2014-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Patients with a definite pleural diseases
• Age more than 18 year-old, less than 85 year-old.
• Willingness to participate in the study.

Exclusion Criteria

• Patients with undiagnosed pleural diseases.
• Age less than 18 year-old or more than 85 year-old.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mesothelin, hyaluronan, osteopontin, syndecan	Mesothelin, hyaluronan, osteopontin, syndecan-1	The patients with pleural diseases

Primary Outcome Measures

Name	Time	Method
Serum N-ERC/mesothelin, C-ERC/mesothelin, hyaluronan, osteopontin and syndecan -1 level in the patients with mesothelioma, metastatic malignant pleural diseases, benign pleural diseases, and benign asbestos pleurisy.	From January 2004 to December 2010	The levels of N-ERC/mesothelin, C-ERC/mesothelin, hyaluronan, osteopontin, and syndecan-1 in the serum samples were established by Enzyme-Linked Immunosorbent Assays (ELISA) at the Division of Pathology, Department of LABMED, Karolinska Institute, Stockholm, Sweden.; All analyses were performed in duplicate by researchers who were unaware of the patient diagnoses. The human N-ERC/mesothelin and osteopontin. ELISA kits were supplied by Immuno-Biological Laboratories Co. Ltd. Japan; the C-ERC/mesothelin ELISA kit was supplied by (MESOMARK™) FDI Fujirebio Diagnostics, Inc.; the hyaluronan ELISA kit (Ref. 029-001) was supplied by Corgenix company; and the syndecan-1 ELISA kit (catalog no. 950.640.096) was supplied by the Diaclone company. Analyses were conducted using a sensitivity TM XS Microplate Sample Processor manufactured by Bio-Tek Instruments Inc (Vermont, USA) in accordance with the manufacturer's instructions. The C-ERC/mesothelin levels were determined at nanomolar levels due

Trial Locations

Locations (1)

ESOGU Lung and Pleural Cancer Application and Research Center; 🇹🇷 Eskisehir, Turkey