Biomarkers to Detect Mesothelioma Early in Patients Exposed to Asbestos or Vermiculite
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.
Genetic: microarray analysis
Genetic: protein expression analysis
Genetic: proteomic profiling
Other: laboratory biomarker analysis
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Early Detection Biomarkers for Mesothelioma Among Asbestos and Vermiculite Exposed Populations|
- Identification of potential drug targets for therapeutic strategies to treat asbestos fiber-related diseases [ Time Frame: At time of analysis ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||October 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897247
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Study Chair:||Anil Wali, PhD||Barbara Ann Karmanos Cancer Institute|