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

Primary Purpose

Malignant Mesothelioma, Metastatic Cancer

Status
Unknown status
Phase
Locations
France
Study Type
Observational
Intervention
laboratory biomarker analysis
study of high risk factors
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Malignant Mesothelioma focused on measuring localized malignant mesothelioma, lung metastases, malignant pleural effusion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de CaenRecruiting

Outcomes

Primary Outcome Measures

Mesothelin and osteopontin concentrations in serum

Secondary Outcome Measures

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

Full Information

First Posted
May 9, 2009
Last Updated
December 13, 2009
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT00899613
Brief Title
Mesothelin and Osteopontin as Diagnostic Markers in Patients With Mesothelioma or Atypical Mesothelial Hyperplasia
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.
Study Type
Observational

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Caen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Mesothelioma, Metastatic Cancer
Keywords
localized malignant mesothelioma, lung metastases, malignant pleural effusion

7. Study Design

Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Procedure
Intervention Name(s)
study of high risk factors
Primary Outcome Measure Information:
Title
Mesothelin and osteopontin concentrations in serum
Secondary Outcome Measure Information:
Title
Cytological, histological, immunohistochemical, and molecular markers of precancerous disease in tissue samples
Title
Role of SV40
Title
Relationship of serum concentration of mesothelin and/or osteopontin with the expression of other markers and with clinical progression

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francoise Galateau-Salle
Organizational Affiliation
University Hospital, Caen
Facility Information:
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francoise Galateau-Salle
Phone
33-231-064-923

12. IPD Sharing Statement

Learn more about this trial

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

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