Genetic Risk Factors and Acquired Oncogenic Mutations of Melanoma (M3)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Though it is generally accepted that exposure to sunlight is a major causative factor for skin cancer, the risk for developing melanoma is not directly linked to sun exposure such as in non-melanoma skin cancer. Therefore, a dual pathway has been proposed, distinguishing melanoma that develops on skin that is chronically exposed to sunlight from those that occur on skin that is normally protected. The risk for each type of melanoma is believed to be determined in part by genetic factors. To define these markers reproducibly, the investigators plan to establish a large cohort with comprehensive information regarding sun sensitivity (skin type), history of experienced sun exposure, skin pigmentation phenotypes, total number of nevi, and other types of skin tumors in a central European population. The investigators will obtain blood from all participants for DNA as well as serum analyses. Based on the finding that genetic variants of the melanocortin-1 receptor (MC1R) gene, associated with red hair and fair skin, have been shown to be associated with increased risk for melanoma, particularly those harboring BRAF mutations, the investigators will now focus on the study of recently discovered genetic variants associated with pigmentation. Furthermore, the investigators will study the relation of these variants with oncogenic mutations of melanoma in BRAF, RAS and c-Kit. The study of other genetic variants will follow, once a sufficiently large cohort has been established to reveal an independent genetic risk factor in a multivariate analysis including potential covariates as mentioned above. The identification of genetic risk factors for melanoma will not only help identify individuals with increased risk but also improve our understanding of the molecular background of the development of melanoma.
| Condition |
|---|
|
Melanoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Genetic Risk Factors and Acquired Oncogenic Mutations of Melanoma |
- melanoma [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2000 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2020 |
| Estimated Primary Completion Date: | December 2020 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
melanoma patients
|
|
2
controls
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Our goal is to recruit at least one thousand melanoma patients of any stage and one thousand controls in order to acquire a well sized cohort for identifying independent molecular markers in multivariate analyses (for statistical considerations see "Statistical analysis" on page 8). Patients who visit the out-door clinic of the Department of Dermatology at the Medical University of Vienna with any other diseases than melanoma, their spouses and spouses of melanoma patients will be asked to contribute as controls.
Inclusion Criteria:
- patients with or without melanoma
Exclusion Criteria:
- HIV and Hepatitis C positive individuals.
Contacts and Locations| Contact: Ichiro Okamoto, MD | +43-1-40400-0 ext 2273 | ichiro.okamoto@meduniwien.ac.at |
| Austria | |
| Medical University of Vienna | Recruiting |
| Vienna, Austria, A-1090 | |
| Contact: Ichiro Okamoto, MD +43-1-40400-0 ext 2273 or 7700 ichiro.okamoto@meduniwien.ac.at | |
More Information
No publications provided
| Responsible Party: | Ichiro Okamoto, associate professor, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00849407 History of Changes |
| Other Study ID Numbers: | M3-I |
| Study First Received: | February 20, 2009 |
| Last Updated: | April 23, 2013 |
| Health Authority: | Austria: Ethikkommission |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 21, 2013