Clinical trial NCT00899613: 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
Overall status: UNKNOWN
Conditions: Malignant Mesothelioma
Metastatic Cancer
Keywords: localized malignant mesothelioma
lung metastases
malignant pleural effusion
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-05-12
Enrollment: 270
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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

Primary outcomes:
measure: Mesothelin and osteopontin concentrations in serum
Secondary outcomes:
measure: Cytological, histological, immunohistochemical, and molecular markers of precancerous disease in tissue samples
measure: Role of SV40
measure: Relationship of serum concentration of mesothelin and/or osteopontin with the expression of other markers and with clinical progression
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
Study officials:
affiliation: University Hospital, Caen
name: Francoise Galateau-Salle
References: