Study of Families With Melanoma

Melanoma (Skin) Clinical Trial

Official title:

Melanoma Family Case-Control Study Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00445783
• Other study ID #: CRUK-LCC-1/3/57
• Secondary ID: CDR0000532934EU-
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2007
• Last updated: August 9, 2013
• Start date: July 2000

Study information

• Verified date: April 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3700
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Genetic:
• gene expression analysis

• mutation analysis

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

Procedure:
• examination

• mutation carrier screening

• study of high risk factors

Locations

Country	Name	City	State
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England

Sponsors (1)

Lead Sponsor	Collaborator
Leeds Cancer Centre at St. James's University Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lifestyle factors governing relapse from melanoma
Primary	Genes governing relapse from melanoma
Primary	Sun exposure and genes that cause melanoma
Primary	Unusual moles related to sun exposure and genes that cause melanoma