Biomarkers to Detect Mesothelioma Early in Patients Exposed to Asbestos or Vermiculite
|ClinicalTrials.gov Identifier: NCT00897247|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : March 5, 2014
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.
|Condition or disease||Intervention/treatment|
|Malignant Mesothelioma Pulmonary Complications||Genetic: microarray analysis Genetic: protein expression analysis Genetic: proteomic profiling Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||494 participants|
|Observational Model:||Case Control|
|Official Title:||Early Detection Biomarkers for Mesothelioma Among Asbestos and Vermiculite Exposed Populations|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||October 2013|
- Identification of potential drug targets for therapeutic strategies to treat asbestos fiber-related diseases [ Time Frame: At time of analysis ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|