Do Your Genes Put You at a Higher Risk of Developing Mesothelioma

November 3, 2017 updated by: Wake Forest University

Consortium for the Sharing of Germ Line DNA and Tissue From Subjects With Mesothelioma

The purpose of this research study is to investigate the possibility that a person's genes put a person at a higher risk of developing mesothelioma. The investigators will examine genes from DNA (genetic material) isolated from blood. This study will also examine the impact of environmental and work exposures and family history of common cancers on the development of mesothelioma. The genetic markers in this study will basically identify how a person's body processes frequently encountered environmental pollutants and will not tell about chromosomes, specific diseases, or other potential health problems.

Study Overview

Status

Completed

Conditions

Detailed Description

Mesothelioma is a cancer that develops from serosal surfaces usually in response to prior asbestos exposure. A history of asbestos exposure can be elicited in more than 80% of mesothelioma victims. However, asbestos exposure alone is not sufficient to cause the development of mesothelioma. Nearly 27 million individuals in the US, were exposed to asbestos in the work place between 1940 and 1979 but just 3,000 new cases of mesothelioma are diagnosed each year. Therefore, the investigators hypothesis is that genetic variation in addition to asbestos exposure, and host factors contribute to the development of mesothelioma. It is estimated, based on the investigators preliminary studies, that a population in excess of 1,000 subjects with mesothelioma is required to perform a valid GWAS.

Therefore a multicenter approach is necessary to collect data and DNA on sufficient numbers with mesothelioma to adequately evaluate genetic risk. It is the aim of this proposal to develop a consortium of mesothelioma investigators to share phenotypic data and DNA samples and to perform genome wide association scanning (GWAS).

Study Type

Observational

Enrollment (Actual)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10016
        • New York University School Of Medicine
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited from the clinics and in patient wards of the academic medical centers noted as collaborators.

Description

Inclusion Criteria:

  • Subjects able to provide informed consent who suffer from mesothelioma

Exclusion Criteria:

  • Inability to provide informed consent
  • Absence of mesothelioma in self

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Mesothelioma
Individuals who have been diagnosed with mesothelioma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Creation of a consortium of investigators (6 sites) for collection of blood for germline DNA and demographic information from 1000 mesothelioma subjects.
Time Frame: Participants will be seen on one occasion lasting 30-60 min to draw blood and elicit demographic information. It will require up to 2 years to enroll 1000 subjects with mesothelioma from the various sites.
Demographic variables that will be collected include; date of birth, gender, age at first exposure to asbestos, type of exposure (occupational or bystander), family health history, personal past medical history, smoking history, age at diagnosis, latency, tumor location and cell type.
Participants will be seen on one occasion lasting 30-60 min to draw blood and elicit demographic information. It will require up to 2 years to enroll 1000 subjects with mesothelioma from the various sites.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GWAS will be performed on the DNA from the 1000 subjects with mesothelioma and compared with 1000 age and asbestos exposure matched controls free of past personal history and family history of cancer.
Time Frame: It will take up to 1 year, after the collection of the 1000 mesothelioma samples, to perform and analyze the GWAS.
Given the significant risk for cancers other than the index mesothelioma in both subjects and their 1st degree relative (nearly 3 fold for sibs, parents and the mesothelioma subjects themselves and 7 fold for their children), the goal is to identify SNPs involved with mesothelioma and other common cancer susceptibility.
It will take up to 1 year, after the collection of the 1000 mesothelioma samples, to perform and analyze the GWAS.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University

Collaborators

Johns Hopkins University
Memorial Sloan Kettering Cancer Center
Mayo Clinic
University of Pennsylvania
NYU Langone Health
Mesothelioma Applied Research Foundation, Inc.

Investigators

  • Study Director: Jill Ohar, MD, Wake Forest University
  • Principal Investigator: Julie Brahmer, MD, Johns Hopkins University
  • Principal Investigator: Harvey I Pass, MD, NYU Langone Health
  • Principal Investigator: Tobias Peikert, MD, Mayo Clinic
  • Principal Investigator: Daniel H Sterman, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 23, 2012

First Submitted That Met QC Criteria

May 1, 2012

First Posted (Estimate)

May 3, 2012

Study Record Updates

Last Update Posted (Actual)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTS 36076 MARF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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