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

Malignant Mesothelioma Clinical Trial

Official title:

Early Detection Biomarkers for Mesothelioma Among Asbestos and Vermiculite Exposed Populations

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Malignant Mesothelioma
• Mesothelioma
• Pulmonary Complications

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