Last updated on December 2009

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


Brief description of study

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 Study Description

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.

Clinical Study Identifier: NCT00899613

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Recruitment Status: Open


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