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

Caen University Hospital

Status: Unknown

Conditions: Metastatic Cancer; Malignant Mesothelioma

Treatments: Procedure: study of high risk factors; Other: laboratory biomarker analysis

Study type: Observational

Funder types: Other

Identifiers

NCT00899613

CDR0000564050

INCA-05-145

INCA-Mesothel

INCA-RECF0433

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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