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

NCT ID: NCT00897247

Last Updated: 2014-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

494 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Malignant Mesothelioma Pulmonary Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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microarray analysis

Intervention Type GENETIC

protein expression analysis

Intervention Type GENETIC

proteomic profiling

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anil Wali, PhD

Role: STUDY_CHAIR

Barbara Ann Karmanos Cancer Institute

Locations

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Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-2006-057

Identifier Type: -

Identifier Source: secondary_id

WSU-HIC-094806MP2F

Identifier Type: -

Identifier Source: secondary_id

CDR0000518348

Identifier Type: -

Identifier Source: org_study_id

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