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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00897247

First received: May 9, 2009

Last updated: May 22, 2009

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 9, 2009

Last Updated Date

May 22, 2009

Start Date ^ICMJE

January 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Identification of potential drug targets for therapeutic strategies to treat asbestos fiber-related diseases [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00897247 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Early Detection Biomarkers for Mesothelioma Among Asbestos and Vermiculite Exposed Populations

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Biospecimen

Sampling Method

Study Population

Condition ^ICMJE

Malignant Mesothelioma
Pulmonary Complications

Intervention ^ICMJE

Genetic: microarray analysis
Genetic: protein expression analysis
Genetic: proteomic profiling
Other: laboratory biomarker analysis

Study Group/Cohort (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

25 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00897247

Other Study ID Numbers ^ICMJE

CDR0000518348, WSU-2006-057, WSU-HIC-094806MP2F

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Barbara Ann Karmanos Cancer Institute

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Anil Wali, PhD

Barbara Ann Karmanos Cancer Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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