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

• Conditions: Malignant Mesothelioma; Metastatic Cancer

• Registration Number: NCT00899613
• Lead Sponsor: University Hospital, Caen

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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Status Verified: 2009-07
• Last Update Submitted: 2009-12-13
• Last Update Posted: 2009-12-15
• Primary Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mesothelin and osteopontin concentrations in serum

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Caen; 🇫🇷 Caen, France