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

Metastatic Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00899613
• Other study ID #: CDR0000564050
• Secondary ID: INCA-RECF0433INC
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2009
• Last updated: December 13, 2009
• Start date: April 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Hyperplasia
• Lung Neoplasms
• Malignant Mesothelioma
• Mesothelioma
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Other:
• laboratory biomarker analysis

Procedure:
• study of high risk factors

Locations

Country	Name	City	State
France	CHU de Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mesothelin and osteopontin concentrations in serum			No
Secondary	Cytological, histological, immunohistochemical, and molecular markers of precancerous disease in tissue samples			No
Secondary	Role of SV40			No
Secondary	Relationship of serum concentration of mesothelin and/or osteopontin with the expression of other markers and with clinical progression			No