Serum Biomarkers in Diagnosis of Mesothelioma

Brief Title

Serum Biomarkers in Diagnosis of Mesothelioma

Official Title

PREDICTING MALIGNANT MESOTHELIOMA BY ANALYZING HYALURONAN, OSTEOPONTIN, C-ERC/MESOTHELIN, N-ERC/MESOTHELIN AND SYNDECAN-1 SERUM LEVELS

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 Type

Observational

Primary Outcome

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.

Condition

Mesothelioma

Intervention

Mesothelin, hyaluronan, osteopontin, syndecan-1

Study Arms / Comparison Groups

 Mesothelin, hyaluronan, osteopontin, syndecan

Description:  The patients with pleural diseases

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

Start Date

January 2004

Completion Date

October 2013

Primary Completion Date

December 2010

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.

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Muzaffer Metintas, Prof.Dr., ,

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations

NCT ID

NCT02029105

Organization ID

2010-280-1

Responsible Party

Principal Investigator

Study Sponsor

Eskisehir Osmangazi University

Study Sponsor

Muzaffer Metintas, Prof.Dr., Study Director, Eskisehir Osmangazi University

Verification Date

January 2014