NCT00897247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
494

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

6.2 years

First QC Date

May 9, 2009

Last Update Submit

March 4, 2014

Conditions

Malignant MesotheliomaPulmonary Complications

Keywords

malignant mesotheliomapulmonary complications

Outcome Measures

Primary Outcomes (1)

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

    At time of analysis

Interventions

microarray analysisGENETIC
protein expression analysisGENETIC
proteomic profilingGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinic

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Microarray Analysis

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Microchip Analytical ProceduresInvestigative Techniques

Study Officials

  • Anil Wali, PhD

    Barbara Ann Karmanos Cancer Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

January 1, 2007

Primary Completion

March 1, 2013

Study Completion

October 1, 2013

Last Updated

March 5, 2014

Record last verified: 2014-03

Locations

US(1)