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

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.

Tracking Information
First Received DateMay 9, 2009
Last Changed DateMarch 4, 2014
Start DateJanuary 2007
Actual Primary Completion DateMarch 2013
Primary Outcome Measures

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

Descriptive Information
PhaseN/A
Study TypeObservational
Condition
  • Malignant Mesothelioma
  • Pulmonary Complications
Intervention
  • Genetic: microarray analysis
  • Genetic: protein expression analysis
  • Genetic: proteomic profiling
  • Other: laboratory biomarker analysis
Study Arms / Comparison Groups0 / 1
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.

Recruitment Information
Recruitment StatusCompleted
Actual Enrollment494
GenderAll
Ages25 Years - 80 Years
Accepts Healthy VolunteersNo
Eligibility 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

Administrative Information
NCTIDNCT00897247
Responsible Party,
SponsorBarbara Ann Karmanos Cancer Institute
Verification DateMarch 2014
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