Clinical trial NCT00445783: Study of Families With Melanoma
Official title: Melanoma Family Case-Control Study Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-03-09
Enrollment: 3700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

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.

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

Primary outcomes:
measure: Lifestyle factors governing relapse from melanoma
measure: Genes governing relapse from melanoma
measure: Sun exposure and genes that cause melanoma
measure: Unusual moles related to sun exposure and genes that cause melanoma
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
Study officials:
affiliation: Leeds Cancer Centre at St. James's University Hospital
name: Julia Newton Bishop, MD
role: STUDY_CHAIR
References: