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

University Hospital, Caen270 enrolled

Overview

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 * 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.

Study Type

OBSERVATIONAL

Enrollment

270

Conditions

Malignant Mesothelioma Metastatic Cancer

Interventions

laboratory biomarker analysisOTHER

study of high risk factorsPROCEDURE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

CHU de Caen

Caen, France

RECRUITING

Outcomes

Primary Outcomes

Mesothelin and osteopontin concentrations in serum

Secondary Outcomes

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

Data from ClinicalTrials.gov

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