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

NCT ID: NCT00899613

Last Updated: 2009-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Brief Summary

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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

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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.

Conditions

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Malignant Mesothelioma Metastatic Cancer

Keywords

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localized malignant mesothelioma lung metastases malignant pleural effusion

Interventions

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laboratory biomarker analysis

Intervention Type OTHER

study of high risk factors

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Principal Investigators

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Francoise Galateau-Salle

Role:

University Hospital, Caen

Locations

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CHU de Caen

Caen, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Francoise Galateau-Salle

Role: primary

Other Identifiers

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INCA-RECF0433

Identifier Type: -

Identifier Source: secondary_id

INCA-05-145

Identifier Type: -

Identifier Source: secondary_id

INCA-Mesothel

Identifier Type: -

Identifier Source: secondary_id

CDR0000564050

Identifier Type: -

Identifier Source: org_study_id