Serum Biomarkers in Diagnosis of Mesothelioma

NCT ID: NCT02029105

Last Updated: 2014-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2013-10-31

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.

Conditions

Mesothelioma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Mesothelin, hyaluronan, osteopontin, syndecan

The patients with pleural diseases

Mesothelin, hyaluronan, osteopontin, syndecan-1

Intervention Type: BIOLOGICAL

We compere the serum levels of the tumor markers in patients with pleural diseases according to the groups for the diagnosis and differential diagnosis of the diseases.

Interventions

Mesothelin, hyaluronan, osteopontin, syndecan-1

We compere the serum levels of the tumor markers in patients with pleural diseases according to the groups for the diagnosis and differential diagnosis of the diseases.

Intervention Type: BIOLOGICAL

Other Intervention Names

N-ERC/mesotehlin,; C-ERC/mesotehlin; Osteopontin; Hyaluronan; Syndecan-1

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eskisehir Osmangazi University

OTHER

Sponsor Role: lead

Responsible Party

Muzaffer Metintas

Eskisehir Osmangazi University Lung and Pleural Cancers Application and Research Center-Turkey; Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muzaffer Metintas, Prof.Dr.

Role: STUDY_DIRECTOR

Eskisehir Osmangazi University

Locations

ESOGU Lung and Pleural Cancer Application and Research Center

Eskişehir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2010-280-1

Identifier Type: -

Identifier Source: org_study_id