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

This study is currently recruiting participants.
Verified November 2013 by Wake Forest School of Medicine
Sponsor:
Collaborators:
University of Pennsylvania
Mayo Clinic
New York University School of Medicine
Johns Hopkins University
Memorial Sloan-Kettering Cancer Center
Mesothelioma Applied Research Foundation, Inc.
Information provided by (Responsible Party):
Jill Ohar MD, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01590472
First received: April 23, 2012
Last updated: November 4, 2013
Last verified: November 2013

April 23, 2012
November 4, 2013
June 2011
December 2014   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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.
Creation of a consortium of investigators (7 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. ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01590472 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Do Your Genes Put You at a Higher Risk of Developing Mesothelioma
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.

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).

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

whole blood

Non-Probability Sample

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

Mesothelioma
Not Provided
Mesothelioma
Individuals who have been diagnosed with mesothelioma

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects able to provide informed consent who suffer from mesothelioma

Exclusion Criteria:

  • Inability to provide informed consent
  • Absence of mesothelioma in self
Both
18 Years and older
No
Contact: Jill Ohar, MD 336-716-4328 johar@wakehealth.edu
Contact: Suzanne Howard showard@wakehealth.edu
United States
 
NCT01590472
GTS 36076 MARF
No
Jill Ohar MD, Wake Forest School of Medicine
Wake Forest School of Medicine
  • University of Pennsylvania
  • Mayo Clinic
  • New York University School of Medicine
  • Johns Hopkins University
  • Memorial Sloan-Kettering Cancer Center
  • Mesothelioma Applied Research Foundation, Inc.
Study Director: Jill Ohar, MD Wake Forest School of Medicine
Principal Investigator: Lee Krug, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Julie Brahmer, MD Johns Hopkins University
Principal Investigator: Harvey I Pass, MD New York University School of Medicine
Principal Investigator: Tobias Peikert, MD Mayo Clinic
Principal Investigator: Daniel H Sterman, MD University of Pennsylvania
Wake Forest School of Medicine
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP