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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysisActive25 and overNCI, OtherCDR0000518348
P30CA022453, WSU-2006-057, WSU-HIC-094806MP2F, 2006-057, NCT00897247

Trial Description

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.

Further Study Information

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Barbara Ann Karmanos Cancer Institute

National Cancer Institute

Anil WaliStudy Chair

Trial Sites

U.S.A.
Michigan
  Detroit
 Barbara Ann Karmanos Cancer Institute
 Cynthia Noraian Ph: 313-578-4282
  Email: noraianc@karmanos.org
 Naimei Tang Ph: 313-578-4265
  Email: ntang@med.wayne.edu

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00897247
Information obtained from ClinicalTrials.gov on April 21, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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