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Status unknownNCT00849407M3Updated Mar 7, 2019

Genetic Risk Factors and Acquired Oncogenic Mutations of Melanoma

An observational study in Melanoma, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-07.

Sponsored by Medical University of Vienna · Observational

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Melanoma

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03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 182 across 438 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

  • patients with or without melanoma

Exclusion criteria

Exclusion Criteria:

  • HIV and Hepatitis C positive individuals.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2,000 participants (estimated)

Groups and cohorts

  • 1

    melanoma patients

  • 2

    controls

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What researchers measure

Primary outcomes

  1. melanoma

    Time frame: 2 years

Secondary outcomes

  1. survival

    Time frame: 10 years

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00849407
Lead sponsor
Medical University of Vienna
Responsible party
Ichiro Okamoto (associate professor, Medical University of Vienna) — Principal investigator
First posted
Feb 23, 2009
Start date
Oct 2008
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Mar 7, 2019

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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