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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00897247
Other study ID # CDR0000518348
Secondary ID P30CA022453WSU-2
Status Completed
Phase N/A
First received May 9, 2009
Last updated March 4, 2014
Start date January 2007
Est. completion date October 2013

Study information

Verified date March 2014
Source Barbara Ann Karmanos Cancer Institute
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Food and Drug Administration
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 494
Est. completion date October 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Intervention

Genetic:
microarray analysis

protein expression analysis

proteomic profiling

Other:
laboratory biomarker analysis


Locations

Country Name City State
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan

Sponsors (2)

Lead Sponsor Collaborator
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of potential drug targets for therapeutic strategies to treat asbestos fiber-related diseases At time of analysis No
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