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Study of Families With Melanoma

This study is currently recruiting participants.
Verified April 2008 by National Cancer Institute (NCI)
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00445783
First received: March 7, 2007
Last updated: August 21, 2010
Last verified: April 2008
History of Changes
  Purpose

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.


Condition Intervention
Melanoma (Skin)
 Genetic: gene expression analysis
Genetic: mutation analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: examination
Procedure: mutation carrier screening
Procedure: study of high risk factors

Study Type: Observational
Official Title: Melanoma Family Case-Control Study Protocol

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 3700
Study Start Date: July 2000
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445783

Locations
United Kingdom
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Contact Person     44-113-206-6400        
Sponsors and Collaborators
Leeds Cancer Centre at St. James's University Hospital
Investigators
Study Chair: Julia Newton Bishop, MD Leeds Cancer Centre at St. James's University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00445783     History of Changes
Other Study ID Numbers: CDR0000532934, CRUK-LCC-1/3/57, EU-20704
Study First Received: March 7, 2007
Last Updated: August 21, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on May 16, 2013