Do Your Genes Put You at a Higher Risk of Developing Mesothelioma
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| ClinicalTrials.gov Identifier: NCT01590472 |
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Recruitment Status :
Completed
First Posted : May 3, 2012
Last Update Posted : November 7, 2017
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| Condition or disease |
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| Mesothelioma |
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).
| Study Type : | Observational |
| Actual Enrollment : | 69 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Cross-Sectional |
| Official Title: | Consortium for the Sharing of Germ Line DNA and Tissue From Subjects With Mesothelioma |
| Study Start Date : | June 2011 |
| Actual Primary Completion Date : | December 2014 |
| Actual Study Completion Date : | December 2015 |
| Group/Cohort |
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Mesothelioma
Individuals who have been diagnosed with mesothelioma
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- 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.
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Subjects able to provide informed consent who suffer from mesothelioma
Exclusion Criteria:
- Inability to provide informed consent
- Absence of mesothelioma in self
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
| 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 | |
| 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 | NYU Langone Health | |
| Principal Investigator: | Tobias Peikert, MD | Mayo Clinic | |
| Principal Investigator: | Daniel H Sterman, MD | University of Pennsylvania |
| Responsible Party: | Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01590472 |
| Other Study ID Numbers: |
GTS 36076 MARF |
| First Posted: | May 3, 2012 Key Record Dates |
| Last Update Posted: | November 7, 2017 |
| Last Verified: | May 2017 |
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Genetics of Mesothelioma Mesothelioma Consortium GWAS Asbestos |
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Mesothelioma Mesothelioma, Malignant Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Pleural Neoplasms Lung Diseases Respiratory Tract Diseases |