Brief Title
Do Your Genes Put You at a Higher Risk of Developing Mesothelioma
Official Title
Consortium for the Sharing of Germ Line DNA and Tissue From Subjects With Mesothelioma
Brief Summary
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.
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
Primary Outcome
Creation of a consortium of investigators (6 sites) for collection of blood for germline DNA and demographic information from 1000 mesothelioma subjects.
Secondary Outcome
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.
Condition
Mesothelioma
Study Arms / Comparison Groups
Mesothelioma
Description: Individuals who have been diagnosed with mesothelioma
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
69
Start Date
June 2011
Completion Date
December 2015
Primary Completion Date
December 2014
Eligibility Criteria
Inclusion Criteria:
- Subjects able to provide informed consent who suffer from mesothelioma
Exclusion Criteria:
- Inability to provide informed consent
- Absence of mesothelioma in self
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jill Ohar, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01590472
Organization ID
GTS 36076 MARF
Responsible Party
Sponsor
Study Sponsor
Wake Forest University
Collaborators
University of Pennsylvania
Study Sponsor
Jill Ohar, MD, Study Director, Wake Forest University
Verification Date
May 2017