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OpenTrials
Completed

NCT Number: NCT00897247

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

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.

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Key information

Conditions

Malignant Mesothelioma Adenoma Lung Diseases Lung Neoplasms Mesothelioma Mesothelioma, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Pleural Neoplasms Pulmonary Complications Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

microarray analysis

Genetic

protein expression analysis

Genetic

proteomic profiling

Genetic

laboratory biomarker analysis

Other

Primary outcomes

  1. Identification of potential drug targets for therapeutic strategies to treat asbestos fiber-related diseases

    Time frame: At time of analysis

Sponsors and collaborators

Lead sponsor

Barbara Ann Karmanos Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Early Detection Biomarkers for Mesothelioma Among Asbestos and Vermiculite Exposed Populations

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
May 12, 2009
Registry last updated
Mar 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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