Studying Genes to Identify Melanoma in Patients in Icelan... | NCT00346008

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

NCT00346008

Sponsor

Iceland Genomics Corporation

Status

Completed

Last Update Posted

May 30, 2013Estimated

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Melanoma (Skin)

Interventions

mutation analysis
high performance liquid chromatography
laboratory biomarker analysis
questionnaire administration

Countries

Iceland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Dec 2008Actual

Completion Date

Feb 2009Actual

First Submitted Date

Jun 27, 2006

First Submission Date that Met QC Criteria

Jun 27, 2006

First Posted Date

Jun 29, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2013

Last Update Posted Date

May 30, 2013Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mutation analysis	Genetic
high performance liquid chromatography	Other
laboratory biomarker analysis	Other
questionnaire administration	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility to identify melanoma
Feasibility to detect mutation
Ability to create datasets

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alisa Goldstein, PhD	National Cancer Institute (NCI)	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Iceland Genomics Corporation		Reykjavik		105	Iceland

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002851	Chromatography, High Pressure Liquid

Ancestor Terms

ID	Term
D002853	Chromatography, Liquid
D002845	Chromatography
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description
NCI-06-C-N026
CDR0000551606	Registry Identifier	PDQ (Physician Data Query)
NBCI-01-087-CM
999906026