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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 9, 2014
Last verified: July 2014
  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 Wake Forest School of Medicine:

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. ] [ 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.


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. ] [ 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.


Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 1000
Study Start Date: June 2011
Estimated Study Completion Date: December 2015
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590472

Contacts
Contact: Jill Ohar, MD 336-716-4328 johar@wakehealth.edu
Contact: Suzanne Howard showard@wakehealth.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Julie R Brahmer, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Tobias Peikert, MD         
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Principal Investigator: Harvey I Pass, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Principal Investigator: Lee Krug, MD         
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Principal Investigator: Jill Ohar, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Daniel H Sterman, MD         
Sponsors and Collaborators
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.
Investigators
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
  More Information

Publications:
Gudmundsson J, Sulem P, Steinthorsdottir V, Bergthorsson JT, Thorleifsson G, Manolescu A, Rafnar T, Gudbjartsson D, Agnarsson BA, Baker A, Sigurdsson A, Benediktsdottir KR, Jakobsdottir M, Blondal T, Stacey SN, Helgason A, Gunnarsdottir S, Olafsdottir A, Kristinsson KT, Birgisdottir B, Ghosh S, Thorlacius S, Magnusdottir D, Stefansdottir G, Kristjansson K, Bagger Y, Wilensky RL, Reilly MP, Morris AD, Kimber CH, Adeyemo A, Chen Y, Zhou J, So WY, Tong PC, Ng MC, Hansen T, Andersen G, Borch-Johnsen K, Jorgensen T, Tres A, Fuertes F, Ruiz-Echarri M, Asin L, Saez B, van Boven E, Klaver S, Swinkels DW, Aben KK, Graif T, Cashy J, Suarez BK, van Vierssen Trip O, Frigge ML, Ober C, Hofker MH, Wijmenga C, Christiansen C, Rader DJ, Palmer CN, Rotimi C, Chan JC, Pedersen O, Sigurdsson G, Benediktsson R, Jonsson E, Einarsson GV, Mayordomo JI, Catalona WJ, Kiemeney LA, Barkardottir RB, Gulcher JR, Thorsteinsdottir U, Kong A, Stefansson K. Two variants on chromosome 17 confer prostate cancer risk, and the one in TCF2 protects against type 2 diabetes. Nat Genet. 2007 Aug;39(8):977-83. Epub 2007 Jul 1.

Responsible Party: Jill Ohar MD, Professor of Medicine, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01590472     History of Changes
Other Study ID Numbers: GTS 36076 MARF
Study First Received: April 23, 2012
Last Updated: July 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Genetics of Mesothelioma
Mesothelioma Consortium
GWAS
Asbestos

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

ClinicalTrials.gov processed this record on August 20, 2014