Mesothelin and Osteopontin as Diagnostic Markers in Patients With Mesothelioma or Atypical Mesothelial Hyperplasia - Full Text View

Sponsored by:	CHU de Caen
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00899613

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:

MedlinePlus related topics: Cancer Mesothelioma

U.S. FDA Resources

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 2004

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

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

CHU de Caen

Investigators

Investigator:

Francoise Galateau-Salle

CHU de Caen

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000564050, INCA-RECF0433, INCA-05-145, INCA-Mesothel
Study First Received:	May 9, 2009
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00899613 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

localized malignant mesothelioma
lung metastases
malignant pleural effusion

Study placed in the following topic categories:

Pleural Effusion
Hyperplasia
Precancerous Conditions
Neoplasm Metastasis

Pleural Effusion, Malignant
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Hyperplasia
Neoplasms by Histologic Type
Pathologic Processes

Neoplasms, Mesothelial
Neoplasm Metastasis
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009