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

NCT01590472 | Completed

• 1 other identifier: GTS 36076 MARF
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 6

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.

Conditions

Mesothelioma

Keywords

Genetics of Mesothelioma; Mesothelioma Consortium; GWAS; Asbestos

Outcome Measures

Primary Outcomes (1)

• Creation of a consortium of investigators (6 sites) for collection of blood for germline DNA and demographic information from 1000 mesothelioma subjects.

  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.

  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 (1)

• 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.

  It will take up to 1 year, after the collection of the 1000 mesothelioma samples, to perform and analyze the GWAS.

Study Arms (1)

Mesothelioma

Individuals who have been diagnosed with mesothelioma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects able to provide informed consent who suffer from mesothelioma

You may not qualify if:

• Inability to provide informed consent
• Absence of mesothelioma in self

Sponsors & Collaborators

• Wake Forest University: lead
• University of Pennsylvania: collaborator
• Mayo Clinic: collaborator
• NYU Langone Health: collaborator
• Johns Hopkins University: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• Mesothelioma Applied Research Foundation, Inc.: collaborator

Study Sites (6)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

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Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Mesothelioma

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial

Study Officials

• Jill Ohar, MD

  Wake Forest University

  STUDY DIRECTOR

• Lee Krug, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Julie Brahmer, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Harvey I Pass, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Tobias Peikert, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Daniel H Sterman, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: May 3, 2012
• Study Start: June 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: November 7, 2017

Record last verified: 2017-05

Locations

US (6)