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

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Locations
Iceland
Study Type
Observational
Intervention
mutation analysis
high performance liquid chromatography
laboratory biomarker analysis
questionnaire administration
Sponsored by
Iceland Genomics Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Melanoma (Skin) focused on measuring melanoma, recurrent melanoma, stage I melanoma, stage II melanoma, stage III melanoma, stage IV melanoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Iceland Genomics Corporation

Outcomes

Primary Outcome Measures

Feasibility to identify melanoma
Feasibility to detect mutation
Ability to create datasets

Secondary Outcome Measures

Full Information

First Posted
June 27, 2006
Last Updated
May 29, 2013
Sponsor
Iceland Genomics Corporation
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00346008
Brief Title
Studying Genes to Identify Melanoma in Patients in Iceland and Their Family Members
Official Title
Genetic Epidemiologic Studies of Melanoma in Iceland
Study Type
Observational

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Iceland Genomics Corporation
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
melanoma, recurrent melanoma, stage I melanoma, stage II melanoma, stage III melanoma, stage IV melanoma

7. Study Design

Enrollment
2500 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
mutation analysis
Intervention Type
Other
Intervention Name(s)
high performance liquid chromatography
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Primary Outcome Measure Information:
Title
Feasibility to identify melanoma
Title
Feasibility to detect mutation
Title
Ability to create datasets

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alisa Goldstein, PhD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Iceland Genomics Corporation
City
Reykjavik
ZIP/Postal Code
105
Country
Iceland

12. IPD Sharing Statement

Learn more about this trial

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

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