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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00899613
First received: May 9, 2009
Last updated: December 13, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention
Malignant Mesothelioma
Metastatic Cancer
Other: laboratory biomarker analysis
Procedure: study of high risk factors

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Mesothelin and osteopontin concentrations in serum [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cytological, histological, immunohistochemical, and molecular markers of precancerous disease in tissue samples [ Designated as safety issue: No ]
  • Role of SV40 [ Designated as safety issue: No ]
  • Relationship of serum concentration of mesothelin and/or osteopontin with the expression of other markers and with clinical progression [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: April 2007
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899613

Locations
France
CHU de Caen Recruiting
Caen, France, 14033
Contact: Francoise Galateau-Salle    33-231-064-923      
Sponsors and Collaborators
University Hospital, Caen
Investigators
Investigator: Francoise Galateau-Salle University Hospital, Caen
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00899613     History of Changes
Other Study ID Numbers: CDR0000564050, INCA-RECF0433, INCA-05-145, INCA-Mesothel
Study First Received: May 9, 2009
Last Updated: December 13, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma
lung metastases
malignant pleural effusion

Additional relevant MeSH terms:
Hyperplasia
Mesothelioma
Neoplasms, Mesothelial
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Lung Neoplasms
Pathologic Processes
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 18, 2014