Biomarkers to Detect Mesothelioma Early in Patients Exposed to Asbestos or Vermiculite

Barbara Ann Karmanos Cancer Institute

Status: Completed

Conditions: Malignant Mesothelioma; Pulmonary Complications

Treatments: Other: laboratory biomarker analysis; Genetic: microarray analysis; Genetic: protein expression analysis; Genetic: proteomic profiling

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00897247

CDR0000518348

WSU-HIC-094806MP2F

P30CA022453 (U.S. NIH Grant/Contract)

WSU-2006-057

Details and patient eligibility

About

RATIONALE: Studying samples of body fluid and blood from patients who have been exposed to asbestos or vermiculite in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking for biomarkers to detect mesothelioma early in patients exposed to asbestos or vermiculite.

Full description

OBJECTIVES:

• Identify patients with known asbestos exposure at early stages of disease development (i.e., indolent premalignant pleural plaques and fibrosis vs malignant pleural mesothelioma).
• Determine the expression levels of tumor-associated proteins in these patients.
• Analyze samples of serum and pleural effusions obtained from these patients.
• Determine the proteomic profile of samples obtained from these patients.
• Determine the molecular mechanisms associated with the regulation of the extracellular matrix microenvironment proteins (e.g., osteonectin, intelectin, or matrix metalloproteins) involved in disease onset and progression.

OUTLINE: This is a multicenter study.

Patients undergo collection of body cavity fluid, including pleural effusion, and blood. Specimens, including fresh frozen malignant pleural mesothelioma tumor tissue, if available, are analyzed for proteomic profile, gene expression profile, and tumor-associated protein expression levels.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Enrollment: 494 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Exposure to vermiculite or asbestos insulation

  • Symptomatic or nonsymptomatic exposure-related disease

• Seen at a clinic in Libby, Montana (CARD Clinic) or Michigan (COEM)

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified