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Serum Biomarkers in Diagnosis of Mesothelioma

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ClinicalTrials.gov Identifier: NCT02029105
Recruitment Status : Completed
First Posted : January 7, 2014
Last Update Posted : January 7, 2014
Sponsor:
Information provided by (Responsible Party):
Muzaffer Metintas, 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.

Condition or disease Intervention/treatment
Mesothelioma Biological: Mesothelin, hyaluronan, osteopontin, syndecan-1

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.

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Study Type : Observational
Actual Enrollment : 230 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: PREDICTING MALIGNANT MESOTHELIOMA BY ANALYZING HYALURONAN, OSTEOPONTIN, C-ERC/MESOTHELIN, N-ERC/MESOTHELIN AND SYNDECAN-1 SERUM LEVELS
Study Start Date : January 2004
Actual Primary Completion Date : December 2010
Actual Study Completion Date : October 2013


Group/Cohort Intervention/treatment
Mesothelin, hyaluronan, osteopontin, syndecan
The patients with pleural diseases
Biological: 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.
Other Names:
  • N-ERC/mesotehlin,
  • C-ERC/mesotehlin
  • Osteopontin
  • Hyaluronan
  • Syndecan-1




Primary Outcome Measures :
  1. 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. [ Time Frame: 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



Biospecimen Retention:   Samples Without DNA
Serum samples of the patients


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with pleural diseases; mesothelioma, metastatic malignant pleural diseases, benign pleural diseases and benign asbestos pleurisy.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029105


Locations
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Turkey
ESOGU Lung and Pleural Cancer Application and Research Center
Eskisehir, Turkey, 260240
Sponsors and Collaborators
Eskisehir Osmangazi University
Investigators
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Study Director: Muzaffer Metintas, Prof.Dr. Eskisehir Osmangazi University

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Responsible Party: Muzaffer Metintas, Eskisehir Osmangazi University Lung and Pleural Cancers Application and Research Center-Turkey; Director, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier: NCT02029105     History of Changes
Other Study ID Numbers: 2010-280-1
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014

Keywords provided by Muzaffer Metintas, Eskisehir Osmangazi University:
Mesothelioma,
Pleural diseases,
Mesothelin,
Osteopontin,
Hyaluronan,
Syndecan-1

Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents