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Trial record 1 of 16 for:    mesothelioma and genetics
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Do Your Genes Put You at a Higher Risk of Developing Mesothelioma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01590472
First Posted: May 3, 2012
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 University Health Sciences
  Purpose
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.

Condition
Mesothelioma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Consortium for the Sharing of Germ Line DNA and Tissue From Subjects With Mesothelioma

Resource links provided by NLM:


Further study details as provided by Jill Ohar MD, Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA
whole blood

Enrollment: 69
Study Start Date: June 2011
Study Completion Date: December 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Mesothelioma
Individuals who have been diagnosed with mesothelioma

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590472


Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Wake Forest University
University of Pennsylvania
Mayo Clinic
New York University School of Medicine
Johns Hopkins University
Memorial Sloan Kettering Cancer Center
Mesothelioma Applied Research Foundation, Inc.
Investigators
Study Director: Jill Ohar, MD Wake Forest University
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
  More Information

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Cerhan JR, Ansell SM, Fredericksen ZS, Kay NE, Liebow M, Call TG, Dogan A, Cunningham JM, Wang AH, Liu-Mares W, Macon WR, Jelinek D, Witzig TE, Habermann TM, Slager SL. Genetic variation in 1253 immune and inflammation genes and risk of non-Hodgkin lymphoma. Blood. 2007 Dec 15;110(13):4455-63. Epub 2007 Sep 7.
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Responsible Party: Jill Ohar MD, Professor of Medicine, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01590472     History of Changes
Other Study ID Numbers: GTS 36076 MARF
First Submitted: April 23, 2012
First Posted: May 3, 2012
Last Update Posted: May 5, 2017
Last Verified: May 2017

Keywords provided by Jill Ohar MD, Wake Forest University Health Sciences:
Genetics of Mesothelioma
Mesothelioma Consortium
GWAS
Asbestos

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial


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