Clinical trial NCT01590472: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mesothelioma
Keywords: Genetics of Mesothelioma
Mesothelioma Consortium
GWAS
Asbestos
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Mayo Clinic
name: NYU Langone Health
name: Johns Hopkins University
name: Memorial Sloan Kettering Cancer Center
name: Mesothelioma Applied Research Foundation, Inc.
First posted: 2012-05-03
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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).

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

Primary outcomes:
measure: Creation of a consortium of investigators (6 sites) for collection of blood for germline DNA and demographic information from 1000 mesothelioma subjects.
timeFrame: 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 outcomes:
measure: 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.
timeFrame: It will take up to 1 year, after the collection of the 1000 mesothelioma samples, to perform and analyze the GWAS.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Wake Forest University
name: Jill Ohar, MD
role: STUDY_DIRECTOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Lee Krug, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Julie Brahmer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Harvey I Pass, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Tobias Peikert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Daniel H Sterman, MD
role: PRINCIPAL_INVESTIGATOR
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