Genetic Risk Factors and Acquired Oncogenic Mutations of Melanoma (M3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Ichiro Okamoto, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00849407
First received: February 20, 2009
Last updated: April 23, 2013
Last verified: April 2013
  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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • melanoma [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

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.

Criteria

Inclusion Criteria:

  • patients with or without melanoma

Exclusion Criteria:

  • HIV and Hepatitis C positive individuals.
  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: NCT00849407

Contacts
Contact: Ichiro Okamoto, MD +43-1-40400-0 ext 2273 ichiro.okamoto@meduniwien.ac.at

Locations
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   
Sponsors and Collaborators
Medical University of Vienna
  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 September 18, 2014