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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00897247
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : March 5, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

Brief 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.

Condition or disease Intervention/treatment
Malignant Mesothelioma Pulmonary Complications Genetic: microarray analysis Genetic: protein expression analysis Genetic: proteomic profiling Other: laboratory biomarker analysis

Detailed Description:


  • 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
Time Perspective: Prospective
Official Title: Early Detection Biomarkers for Mesothelioma Among Asbestos and Vermiculite Exposed Populations
Study Start Date : January 2007
Primary Completion Date : March 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Identification of potential drug targets for therapeutic strategies to treat asbestos fiber-related diseases [ Time Frame: At time of analysis ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population


  • Exposure to vermiculite or asbestos insulation

    • Symptomatic or nonsymptomatic exposure-related disease
  • Seen at a clinic in Libby, Montana (CARD Clinic) or Michigan (COEM)


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00897247

United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Anil Wali, PhD Barbara Ann Karmanos Cancer Institute

Responsible Party: Barbara Ann Karmanos Cancer Institute Identifier: NCT00897247     History of Changes
Other Study ID Numbers: CDR0000518348
P30CA022453 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Keywords provided by Barbara Ann Karmanos Cancer Institute:
malignant mesothelioma
pulmonary complications

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases