Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-01-09 @ 9:13 AM
Study NCT ID:
NCT02029105
Status:
COMPLETED
Last Update Posted:
2014-01-07
First Post:
2014-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Biomarkers in Diagnosis of Mesothelioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D010995', 'term': 'Pleural Diseases'}], 'ancestors': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090204', 'term': 'Mesothelin'}, {'id': 'D006820', 'term': 'Hyaluronic Acid'}, {'id': 'D053495', 'term': 'Osteopontin'}, {'id': 'D053668', 'term': 'Syndecan-1'}], 'ancestors': [{'id': 'D058851', 'term': 'GPI-Linked Proteins'}, {'id': 'D008562', 'term': 'Membrane Glycoproteins'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D058635', 'term': 'Lipid-Linked Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D000954', 'term': 'Antigens, Surface'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D012795', 'term': 'Sialoglycoproteins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D016326', 'term': 'Extracellular Matrix Proteins'}, {'id': 'D012596', 'term': 'Scleroproteins'}, {'id': 'D053667', 'term': 'Syndecans'}, {'id': 'D019812', 'term': 'Heparan Sulfate Proteoglycans'}, {'id': 'D011509', 'term': 'Proteoglycans'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum samples of the patients'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-06', 'studyFirstSubmitDate': '2014-01-06', 'studyFirstSubmitQcDate': '2014-01-06', 'lastUpdatePostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': "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.\n\nAll 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"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mesothelioma,', 'Pleural diseases,', 'Mesothelin,', 'Osteopontin,', 'Hyaluronan,', 'Syndecan-1'], 'conditions': ['Mesothelioma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pleural diseases; mesothelioma, metastatic malignant pleural diseases, benign pleural diseases and benign asbestos pleurisy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a definite pleural diseases\n* Age more than 18 year-old, less than 85 year-old.\n* Willingness to participate in the study.\n\nExclusion Criteria:\n\n* Patients with undiagnosed pleural diseases.\n* Age less than 18 year-old or more than 85 year-old.'}, 'identificationModule': {'nctId': 'NCT02029105', 'briefTitle': 'Serum Biomarkers in Diagnosis of Mesothelioma', 'organization': {'class': 'OTHER', 'fullName': 'Eskisehir Osmangazi University'}, 'officialTitle': 'PREDICTING MALIGNANT MESOTHELIOMA BY ANALYZING HYALURONAN, OSTEOPONTIN, C-ERC/MESOTHELIN, N-ERC/MESOTHELIN AND SYNDECAN-1 SERUM LEVELS', 'orgStudyIdInfo': {'id': '2010-280-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mesothelin, hyaluronan, osteopontin, syndecan', 'description': 'The patients with pleural diseases', 'interventionNames': ['Biological: Mesothelin, hyaluronan, osteopontin, syndecan-1']}], 'interventions': [{'name': 'Mesothelin, hyaluronan, osteopontin, syndecan-1', 'type': 'BIOLOGICAL', 'otherNames': ['N-ERC/mesotehlin,', 'C-ERC/mesotehlin', 'Osteopontin', 'Hyaluronan', 'Syndecan-1'], 'description': '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.', 'armGroupLabels': ['Mesothelin, hyaluronan, osteopontin, syndecan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '260240', 'city': 'Eskişehir', 'country': 'Turkey (Türkiye)', 'facility': 'ESOGU Lung and Pleural Cancer Application and Research Center', 'geoPoint': {'lat': 39.77667, 'lon': 30.52056}}], 'overallOfficials': [{'name': 'Muzaffer Metintas, Prof.Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eskisehir Osmangazi University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eskisehir Osmangazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Eskisehir Osmangazi University Lung and Pleural Cancers Application and Research Center-Turkey; Director', 'investigatorFullName': 'Muzaffer Metintas', 'investigatorAffiliation': 'Eskisehir Osmangazi University'}}}}