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| ID | Type | Description | Link |
|---|---|---|---|
| INCA-RECF0433 | |||
| INCA-05-145 | |||
| INCA-Mesothel |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other | |||
| study of high risk factors | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Mesothelin and osteopontin concentrations in serum |
| 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 |
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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:
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
Exclusion criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Francoise Galateau-Salle | University Hospital, Caen |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Caen | Recruiting | Caen | 14033 | France |
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| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| D009362 | Neoplasm Metastasis |
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| D009369 |
| Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |