Studying Genes to Identify Melanoma in Patients in Iceland and Their Family Members - Full Text View

Sponsors and Collaborators:	Iceland Genomics Corporation National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00346008

Purpose

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	Intervention
Melanoma (Skin)	Genetic: mutation analysis Other: high performance liquid chromatography Other: laboratory biomarker analysis Other: questionnaire administration

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Study Type:	Observational
Official Title:	Genetic Epidemiologic Studies of Melanoma in Iceland

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Feasibility to identify melanoma [ Designated as safety issue: No ]
Feasibility to detect mutation [ Designated as safety issue: No ]
Ability to create datasets [ Designated as safety issue: No ]

Estimated Enrollment:	2500
Study Start Date:	October 2005
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346008

Locations

Iceland
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)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000551606, NCI-06-C-N026, NBCI-03-033-CM, NBCI-01-087-CM, 999906026
Study First Received:	June 27, 2006
Last Updated:	February 18, 2009
ClinicalTrials.gov Identifier:	NCT00346008 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

melanoma
recurrent melanoma
stage I melanoma

stage II melanoma
stage III melanoma
stage IV melanoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on May 07, 2009