Study of Families With Melanoma
Primary Purpose
Melanoma (Skin)
Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
gene expression analysis
mutation analysis
immunohistochemistry staining method
laboratory biomarker analysis
examination
mutation carrier screening
study of high risk factors
Sponsored by
About this trial
This is an observational trial for Melanoma (Skin) focused on measuring lentigo maligna malignant melanoma, stage IV melanoma, acral lentiginous malignant melanoma, nodular malignant melanoma, stage IA melanoma, stage IB melanoma, stage IIA melanoma, stage IIB melanoma, stage IIC melanoma, stage IIIA melanoma, stage IIIB melanoma, stage IIIC melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Newly diagnosed primary invasive melanoma (patient group)
- Lentigo maligna malignant melanoma allowed
Rare variants of melanoma allowed, including any of the following:
- Acral lentiginous
- Subungual
- Ear, nose, and throat
- Oropharyngeal
- Perineal
- Vaginal
- Vulval
- Rectal
- Nodal with no known primary
- Patients undergoing sentinel node biopsy are eligible
- No in situ melanoma, melanocytic intraepidermal neoplasia, or ocular melanoma
Healthy participant meeting either of the following criteria (control group):
- Relative of a patient who was diagnosed with melanoma after September 2005
- Healthy volunteer who is age- and sex-matched for patients who were diagnosed with melanoma before October 2005
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Sites / Locations
- Leeds Cancer Centre at St. James's University HospitalRecruiting
Outcomes
Primary Outcome Measures
Lifestyle factors governing relapse from melanoma
Genes governing relapse from melanoma
Sun exposure and genes that cause melanoma
Unusual moles related to sun exposure and genes that cause melanoma
Secondary Outcome Measures
Full Information
NCT ID
NCT00445783
First Posted
March 7, 2007
Last Updated
August 9, 2013
Sponsor
Leeds Cancer Centre at St. James's University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00445783
Brief Title
Study of Families With Melanoma
Official Title
Melanoma Family Case-Control Study Protocol
Study Type
Observational
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2000 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Leeds Cancer Centre at St. James's University Hospital
4. Oversight
5. Study Description
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.
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 (e.g., 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 3,700 patients and healthy participants will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
lentigo maligna malignant melanoma, stage IV melanoma, acral lentiginous malignant melanoma, nodular malignant melanoma, stage IA melanoma, stage IB melanoma, stage IIA melanoma, stage IIB melanoma, stage IIC melanoma, stage IIIA melanoma, stage IIIB melanoma, stage IIIC melanoma
7. Study Design
Enrollment
3700 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
mutation analysis
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Procedure
Intervention Name(s)
examination
Intervention Type
Procedure
Intervention Name(s)
mutation carrier screening
Intervention Type
Procedure
Intervention Name(s)
study of high risk factors
Primary Outcome Measure Information:
Title
Lifestyle factors governing relapse from melanoma
Title
Genes governing relapse from melanoma
Title
Sun exposure and genes that cause melanoma
Title
Unusual moles related to sun exposure and genes that cause melanoma
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Newly diagnosed primary invasive melanoma (patient group)
Lentigo maligna malignant melanoma allowed
Rare variants of melanoma allowed, including any of the following:
Acral lentiginous
Subungual
Ear, nose, and throat
Oropharyngeal
Perineal
Vaginal
Vulval
Rectal
Nodal with no known primary
Patients undergoing sentinel node biopsy are eligible
No in situ melanoma, melanocytic intraepidermal neoplasia, or ocular melanoma
Healthy participant meeting either of the following criteria (control group):
Relative of a patient who was diagnosed with melanoma after September 2005
Healthy volunteer who is age- and sex-matched for patients who were diagnosed with melanoma before October 2005
PATIENT CHARACTERISTICS:
Not specified
PRIOR CONCURRENT THERAPY:
Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Newton Bishop, MD
Organizational Affiliation
Leeds Cancer Centre at St. James's University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-113-206-6400
12. IPD Sharing Statement
Learn more about this trial
Study of Families With Melanoma
We'll reach out to this number within 24 hrs