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

December 13, 2009 updated by: University Hospital, Caen

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14033
        • Recruiting
        • CHU de Caen
        • Contact:
          • Francoise Galateau-Salle
          • Phone Number: 33-231-064-923

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mesothelin and osteopontin concentrations in serum

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Francoise Galateau-Salle, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

December 15, 2009

Last Update Submitted That Met QC Criteria

December 13, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000564050
  • INCA-RECF0433
  • INCA-05-145
  • INCA-Mesothel

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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