Melanoma (Skin)NCT00346008
Studying Genes to Identify Melanoma in Patients in Iceland and Their Family Members
An observational study of Melanoma (Skin), run by Iceland Genomics Corporation at 1 site in Iceland.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- mutation analysis, high performance liquid chromatography and laboratory biomarker analysis
- How many people
- 2,500 participants
- Where
- 1 siteIceland
- Study dates
- Oct 2005to Feb 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetic Epidemiologic Studies of Melanoma in Iceland
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.
Read the 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.
- Conditions
- Melanoma (Skin)
- Being tested
- mutation analysis, high performance liquid chromatography, laboratory biomarker analysis, questionnaire administration
- Keywords
- melanoma, recurrent melanoma, stage I melanoma, stage II melanoma, stage III melanoma, stage IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mutation analysisGenetic
high performance liquid chromatographyOther
laboratory biomarker analysisOther
questionnaire administrationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility to identify melanoma
Feasibility to detect mutation
Ability to create datasets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study startOct 2005
- Primary completionDec 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iceland Genomics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Alisa Goldstein, PhD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346008
- Sponsor's protocol ID
- NBCI-03-033-CM
- Other IDs
- NCI-06-C-N026, CDR0000551606, NBCI-01-087-CM, 999906026
- Status last verified
- Dec 2008
- First submitted
- 27 Jun 2006
- Last updated
- 30 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Epidemiologic Studies of Melanoma in Iceland
- ClinicalTrials.gov ID
- NCT00346008
- Acronym / sponsor ID
- NBCI-03-033-CM
- Conditions
- Melanoma (Skin)
- Keywords
- melanoma, recurrent melanoma, stage I melanoma, stage II melanoma, stage III melanoma, stage IV melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Iceland Genomics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 29 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mutation analysis | Genetic | – |
| high performance liquid chromatography | Other | – |
| laboratory biomarker analysis | Other | – |
| questionnaire administration | Other | – |
Primary outcome
Feasibility to identify melanoma
Feasibility to detect mutation
Ability to create datasets
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alisa Goldstein, PhD study chair
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma (Skin), run by Iceland Genomics Corporation at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility to identify melanoma. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2013.