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Study of Families With Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00445783
Recruitment Status : Recruiting
First Posted : March 9, 2007
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment
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

Detailed Description:



  • Determine what lifestyle factors and which genes govern relapse from melanoma.


  • 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.

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Study Type : Observational
Estimated Enrollment : 3700 participants
Official Title: Melanoma Family Case-Control Study Protocol
Study Start Date : July 2000
Estimated Primary Completion Date : December 2020

Primary Outcome Measures :
  1. Lifestyle factors governing relapse from melanoma
  2. Genes governing relapse from melanoma
  3. Sun exposure and genes that cause melanoma
  4. Unusual moles related to sun exposure and genes that cause melanoma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • 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


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00445783

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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
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Study Chair: Julia Newton Bishop, MD Leeds Cancer Centre at St. James's University Hospital

Layout table for additonal information Identifier: NCT00445783     History of Changes
Other Study ID Numbers: CRUK-LCC-1/3/57
CDR0000532934 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: March 9, 2007    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: April 2008
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:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas