Mesothelin and Osteopontin as Diagnostic Markers in Patients With Mesothelioma or Atypical Mesothelial Hyperplasia

Study Overview
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Brief Summary
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RATIONALE: Studying levels of mesothelin and osteopontin in samples of blood from patients with mesothelioma or atypical mesothelial hyperplasia may help doctors identify biomarkers related to cancer. PURPOSE: This research study is looking at mesothelin and osteopontin as diagnostic markers in patients with mesothelioma or atypical hyperplasia.

Detailed Description
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OBJECTIVES: Primary Determine if mesothelin and osteopontin in serum can serve as early markers of malignant transformation into mesothelioma. Secondary Determine if there are cytological, histological, immunohistochemical, and molecular markers of precancerous disease in tissue samples. Determine if SV40 has a carcinogenic role. Determine the relationship between the serum concentration of mesothelin and/or osteopontin and the expression of other markers and with clinical progression. OUTLINE: This is a multicenter study. Levels of mesothelin and osteopontin in serum (and pleural fluid, if effusion is present) are measured at baseline and 3, 6, 12, and 24 months. Patients with mesothelioma, reactional lesions, or adenocarcinoma undergo tomodensitometry (TDM) at baseline, 3, 6, and 12 months. Patients with pleural plaques only undergo TDM at 12 months. Patients are followed for 5 years.

Official Title
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Study Aiming at Researching Diagnostic Markers for the Recognition of Precancerous States, Tracking, Follow-up, and the Identification of New Therapeutic Targets for Mesothelioma in Patients With Atypical Mesothelial Hyperplasia.

Conditions
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Malignant Mesothelioma, Metastatic Cancer

Intervention / Treatment
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* Other: laboratory biomarker analysis
* Procedure: study of high risk factors


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Inclusion criteria: Diagnosis of mesothelial hyperplasia and meeting 1 of the following criteria: Confirmed prior exposure to asbestos and presence of pleural effusion and meets 1 of the following diagnostic criteria: Mesothelioma Mesothelial hyperplasia of unspecified malignancy Reactional inflammatory hyperplasia No asbestos exposure but pleural effusion with pleural malignant mesothelioma or pulmonary metastasis Prior exposure to asbestos, no pleural effusion, and asymptomatic (pleural plaques present) No prior exposure to asbestos but with benign pleural effusion Tissue obtained by pleuroscopy, surgical biopsy, or video-thoracoscopy available Paraffin-embedded and frozen tissue available Exclusion criteria: Solitary fibrous tumor Diffuse pleural fibrosis Purulent pleurisy PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: laboratory biomarker analysis|nan|
|Procedure: study of high risk factors|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mesothelin and osteopontin concentrations in serum |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytological, histological, immunohistochemical, and molecular markers of precancerous disease in tissue samples |  |  | 
| Role of SV40 |  |  | 
| Relationship of serum concentration of mesothelin and/or osteopontin with the expression of other markers and with clinical progression |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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localized malignant mesothelioma, lung metastases, malignant pleural effusion