Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445783
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2007-03-07
Brief Title:
Study of Families With Melanoma
Sponsor:
Leeds Cancer Centre at St Jamess University Hospital
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Melanoma Family Case-Control Study Protocol
Status:
UNKNOWN
Status Verified Date:
2008-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE A study that evaluates patients lifestyle skin and blood and tissue samples may help doctors understand the risk factors for melanoma relapse
PURPOSE This clinical trial is studying the risk factors for melanoma in families with melanoma
PURPOSE This clinical trial is studying the risk factors for melanoma in families with melanoma
Detailed Description:
OBJECTIVES
Primary
Determine what lifestyle factors and which genes govern relapse from melanoma
Secondary
Compare sun exposure and genes that cause melanoma in patients with melanoma vs healthy participants
Assess how unusual moles relate to sun exposure and genes that cause melanoma
OUTLINE This is a multicenter cohort study
Patients and healthy participants complete lifestyle questionnaires by mail and telephone Some patients and healthy participants undergo a skin examination to count moles and classify skin type eg degree of freckling and wrinkling indicative of sun damage
NOTE Patients diagnosed with primary invasive melanoma after September 2005 do not need to consent to a skin examination
Patients and healthy participants also undergo blood collection for lymphocyte analysis DNA extraction and the measurement of minerals vitamins and beta carotene Tissue samples from original diagnosis are examined by immunohistochemistry for gene expression and mutations including CDKN2A and CDK4
Patients and healthy participants are followed annually
Peer reviewed and funded or endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 3700 patients and healthy participants will be accrued for this study
Primary
Determine what lifestyle factors and which genes govern relapse from melanoma
Secondary
Compare sun exposure and genes that cause melanoma in patients with melanoma vs healthy participants
Assess how unusual moles relate to sun exposure and genes that cause melanoma
OUTLINE This is a multicenter cohort study
Patients and healthy participants complete lifestyle questionnaires by mail and telephone Some patients and healthy participants undergo a skin examination to count moles and classify skin type eg degree of freckling and wrinkling indicative of sun damage
NOTE Patients diagnosed with primary invasive melanoma after September 2005 do not need to consent to a skin examination
Patients and healthy participants also undergo blood collection for lymphocyte analysis DNA extraction and the measurement of minerals vitamins and beta carotene Tissue samples from original diagnosis are examined by immunohistochemistry for gene expression and mutations including CDKN2A and CDK4
Patients and healthy participants are followed annually
Peer reviewed and funded or endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 3700 patients and healthy participants will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20704 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000532934 | REGISTRY | None | None |