Clinical trial NCT02029105: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mesothelioma
Keywords: Mesothelioma,
Pleural diseases,
Mesothelin,
Osteopontin,
Hyaluronan,
Syndecan-1
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pleural diseases; mesothelioma, metastatic malignant pleural diseases, benign pleural diseases and benign asbestos pleurisy.

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.

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.

Primary outcomes:
measure: 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.
timeFrame: From January 2004 to December 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: ESOGU Lung and Pleural Cancer Application and Research Center
Study officials:
affiliation: Eskisehir Osmangazi University
name: Muzaffer Metintas, Prof.Dr.
role: STUDY_DIRECTOR
References: