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

Mesothelioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590472
• Other study ID #: GTS 36076 MARF
• Status: Completed
• Phase: N/A
• First received: April 23, 2012
• Last updated: November 3, 2017
• Start date: June 2011
• Est. completion date: December 2015

Study information

• Verified date: May 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects able to provide informed consent who suffer from mesothelioma

Exclusion Criteria:

• Inability to provide informed consent

• Absence of mesothelioma in self

Related Conditions & MeSH terms

• Mesothelioma

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	New York University School of Medicine	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (7)

Lead Sponsor	Collaborator
Wake Forest University	Johns Hopkins University, Mayo Clinic, Memorial Sloan Kettering Cancer Center, Mesothelioma Applied Research Foundation, Inc., New York University School of Medicine, University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creation of a consortium of investigators (6 sites) for collection of blood for germline DNA and demographic information from 1000 mesothelioma subjects.	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	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.	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.