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临床试验/NCT02029105
NCT02029105已完成不适用

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

Eskisehir Osmangazi University1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2004年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
230
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a definite pleural diseases
  • Age more than 18 year-old, less than 85 year-old.
  • Willingness to participate in the study.

排除标准

  • Patients with undiagnosed pleural diseases.
  • Age less than 18 year-old or more than 85 year-old.

结局指标

主要结局

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.

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Eskisehir Osmangazi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muzaffer Metintas

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

Eskisehir Osmangazi University

研究点 (1)

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