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CompletedNCT00897247Updated Mar 5, 2014

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

An observational study in Malignant Mesothelioma and Pulmonary Complications, sponsored by Barbara Ann Karmanos Cancer Institute. Completed at 1 site in United States. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-03-05.

Sponsored by Barbara Ann Karmanos Cancer Institute · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
494
Ages
25 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Malignant Mesothelioma
  • Pulmonary Complications

Keywords

  • malignant mesothelioma
  • pulmonary complications
03

In context

Mesothelioma

470 studies on the registry are indexed under Mesothelioma; 75 are open to participants now.

This study's enrollment of 494 is above the median of 150 across 64 observational studies indexed under Mesothelioma.

Browse Mesothelioma studies →

Lead sponsor

Barbara Ann Karmanos Cancer Institute is the lead sponsor of 158 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Clinic

Eligibility 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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
494 participants (actual)

Interventions

  • Geneticmicroarray analysis
  • Geneticprotein expression analysis
  • Geneticproteomic profiling
  • Otherlaboratory biomarker analysis
06

What researchers measure

Primary outcomes

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

    Time frame: At time of analysis

07

Study locations

1 site
  • Barbara Ann Karmanos Cancer Institute
    Detroit, Michigan 48201-1379, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00897247
Lead sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 12, 2009
Start date
Jan 2007
Primary completion
Mar 2013
Completion
Oct 2013
Last update
Mar 5, 2014

Study contacts

Anil Wali, PhD
study chair · Barbara Ann Karmanos Cancer Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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