Studying Genes to Identify Melanoma in Patients in Iceland and Their Family Members

• Sponsor: Iceland Genomics Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00346008
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 2,500
• Location: 1
• Duration (Months): 40
• Patients Per Site Per Month: 62.4

Study Details

Study Description

Brief Summary

RATIONALE: Studying the genes expressed in samples of blood from patients with cancer and their family members may help doctors identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying genes to identify melanoma in patients in Iceland and their family members.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin)	Genetic: mutation analysis; Other: high performance liquid chromatography; Other: laboratory biomarker analysis; Other: questionnaire administration

Detailed Description

OBJECTIVES:

• Assess the feasibility of Iceland Genomics Corporation (UVS) to identify melanoma in multiple-case families, individuals with multiple tumors, and selected additional family members in Iceland.

• Assess the feasibility of mutation detection using sequencing and HPLC.

• Determine UVS' ability to create datasets with demographic, epidemiologic and molecular data.

OUTLINE: Participants and patients undergo blood collection and complete lifestyle questionnaires. All patients and population-based controls have DNA samples sequenced for MC1R. Demographic and epidemiologic data on all study participants is collected. Sequencing of the major melanoma susceptibility genes CFDKN2A, CDK4, and MC1R is also performed.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2500 participants
• Official Title: Genetic Epidemiologic Studies of Melanoma in Iceland
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Feb 1, 2009

Outcome Measures

Primary Outcome Measures

1. Feasibility to identify melanoma []

2. Feasibility to detect mutation []

3. Ability to create datasets []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

DISEASE CHARACTERISTICS:

• Patients diagnosed with melanoma and selected family members are eligible to participate

• Must live in Iceland

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iceland Genomics Corporation	Reykjavik		Iceland	105

Sponsors and Collaborators

• Iceland Genomics Corporation
• National Cancer Institute (NCI)

Investigators

• Study Chair: Alisa Goldstein, PhD, National Cancer Institute (NCI)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00346008
• Other Study ID Numbers: NBCI-03-033-CM; NCI-06-C-N026; CDR0000551606; NBCI-01-087-CM; 999906026; NCT00482534
• First Posted: Jun 29, 2006
• Last Update Posted: May 30, 2013
• Last Verified: Dec 1, 2008

• Keywords provided by , ,: melanoma; recurrent melanoma; stage I melanoma; stage II melanoma; stage III melanoma; stage IV melanoma
• Additional relevant MeSH terms: Melanoma

Study Results

No Results Posted as of May 30, 2013