NCT00897247

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

Early Detection Biomarkers for Mesothelioma Among Asbestos and Vermiculite Exposed Populations

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 494 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Malignant Mesothelioma
• Pulmonary Complications

Interventions

Type	Name	Description
GENETIC	microarray analysis
GENETIC	protein expression analysis
GENETIC	proteomic profiling
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2007-01-01
• Primary completion: 2013-03-01
• Completion: 2013-10-01
• First posted: 2009-05-12
• Last updated: 2014-03-05

Locations

1 site across 1 country: United States