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

Melanoma (Skin) Clinical Trial

Official title:

Genetic Epidemiologic Studies of Melanoma in Iceland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346008
• Other study ID #: NBCI-03-033-CM
• Secondary ID: NCI-06-C-N026CDR
• Status: Completed
• Phase: N/A
• First received: June 27, 2006
• Last updated: May 29, 2013
• Start date: October 2005
• Est. completion date: February 2009

Study information

• Verified date: December 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00482534

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Genetic:
• mutation analysis

Other:
• high performance liquid chromatography

• laboratory biomarker analysis

• questionnaire administration

Locations

Country	Name	City	State
Iceland	Iceland Genomics Corporation	Reykjavik

Sponsors (2)

Lead Sponsor	Collaborator
Iceland Genomics Corporation	National Cancer Institute (NCI)

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility to identify melanoma			No
Primary	Feasibility to detect mutation			No
Primary	Ability to create datasets			No