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

This study is currently recruiting participants.

Verified January 2013 by Wake Forest University

Sponsor:

Collaborators:

University of Pennsylvania

Mayo Clinic

New York University School of Medicine

Johns Hopkins University

Mount Sinai School of Medicine

Memorial Sloan-Kettering Cancer Center

Mesothelioma Applied Research Foundation, Inc.

Information provided by (Responsible Party):

Jill Ohar MD, Wake Forest University

ClinicalTrials.gov Identifier:

NCT01590472

First received: April 23, 2012

Last updated: January 7, 2013

Last verified: January 2013

History of Changes

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:

MedlinePlus related topics: Asbestos Cancer Mesothelioma

U.S. FDA Resources

Further study details as provided by Wake Forest University:

Primary Outcome Measures:

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.

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 2014
Estimated Primary Completion Date:	December 2013 (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

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
Mount Sinai School of Medicine	Not yet recruiting
New York, New York, United States, 10029
Principal Investigator: Raja Flores, 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 University

University of Pennsylvania

Mayo Clinic

New York University School of Medicine

Johns Hopkins University

Mount Sinai School of Medicine

Memorial Sloan-Kettering Cancer Center

Mesothelioma Applied Research Foundation, Inc.

Investigators

Study Director:	Jill Ohar, MD	Wake Forest University
Principal Investigator:	Raja Flores, MD	Mount Sinai 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

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Rai AJ, Flores RM, Mathew A, Gonzalez-Espinoza R, Bott M, Ladanyi M, Rusch V, Fleisher M. Soluble mesothelin related peptides (SMRP) and osteopontin as protein biomarkers for malignant mesothelioma: analytical validation of ELISA based assays and characterization at mRNA and protein levels. Clin Chem Lab Med. 2010 Feb;48(2):271-8.

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Ohashi R, Tajima K, Takahashi F, Cui R, Gu T, Shimizu K, Nishio K, Fukuoka K, Nakano T, Takahashi K. Osteopontin modulates malignant pleural mesothelioma cell functions in vitro. Anticancer Res. 2009 Jun;29(6):2205-14.

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Responsible Party:	Jill Ohar MD, Professor of Medicine, Wake Forest University
ClinicalTrials.gov Identifier:	NCT01590472 History of Changes
Other Study ID Numbers:	GTS 36076 MARF
Study First Received:	April 23, 2012
Last Updated:	January 7, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Wake Forest University:

Genetics of Mesothelioma
Mesothelioma Consortium
GWAS
Asbestos

Additional relevant MeSH terms:

Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on June 18, 2013

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