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

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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00899613

Enrollment

270

Registered

2009-05-12

Start date

2007-04-30

Completion date

Unknown

Last updated

2009-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Mesothelioma, Metastatic Cancer

Keywords

localized malignant mesothelioma, lung metastases, malignant pleural effusion

Brief summary

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 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.

Interventions

OTHERlaboratory biomarker analysis

PROCEDUREstudy of high risk factors

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mesothelin and osteopontin concentrations in serum	—

Secondary

Measure	Time frame
Relationship of serum concentration of mesothelin and/or osteopontin with the expression of other markers and with clinical progression	—
Cytological, histological, immunohistochemical, and molecular markers of precancerous disease in tissue samples	—
Role of SV40	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026