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

This study is currently recruiting participants.
Verified April 2013 by Barbara Ann Karmanos Cancer Institute
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Naimei Tang, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00897247
First received: May 9, 2009
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Malignant Mesothelioma
Pulmonary Complications
 Genetic: microarray analysis
Genetic: protein expression analysis
Genetic: proteomic profiling
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Early Detection Biomarkers for Mesothelioma Among Asbestos and Vermiculite Exposed Populations

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Identification of potential drug targets for therapeutic strategies to treat asbestos fiber-related diseases [ Time Frame: At time of analysis ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2007
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Clinic

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897247

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Cynthia Noraian     313-578-4282     noraianc@karmanos.org    
Contact: Naimei Tang     313-578-4265     ntang@med.wayne.edu    
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
Study Chair: Anil Wali, PhD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Naimei Tang, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00897247     History of Changes
Other Study ID Numbers: CDR0000518348, P30CA022453, WSU-2006-057, WSU-HIC-094806MP2F
Study First Received: May 9, 2009
Last Updated: April 18, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on May 19, 2013