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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00897247

Enrollment

494

Registered

2009-05-12

Start date

2007-01-31

Completion date

2013-10-31

Last updated

2014-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Mesothelioma, Pulmonary Complications

Keywords

malignant mesothelioma, pulmonary complications

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.

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.

Interventions

GENETICmicroarray analysis

GENETICprotein expression analysis

GENETICproteomic profiling

OTHERlaboratory biomarker analysis

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

25 Years to 80 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Identification of potential drug targets for therapeutic strategies to treat asbestos fiber-related diseases	At time of analysis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026