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.
N/A
N/A
Both
Malignant Mesothelioma, Metastatic Cancer
Trial Information
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.
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.
Inclusion 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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Mesothelin and osteopontin concentrations in serum
Safety Issue:
No
Principal Investigator
Francoise Galateau-Salle
Investigator Affiliation:
University Hospital, Caen
Authority:
Unspecified
Study ID:
CDR0000564050
NCT ID:
NCT00899613
Start Date:
April 2007
Completion Date:
Related Keywords:
- Malignant Mesothelioma
- Metastatic Cancer
- localized malignant mesothelioma
- lung metastases
- malignant pleural effusion
- Hyperplasia
- Mesothelioma
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
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