Study of Families With Melanoma

August 9, 2013 updated by: Leeds Cancer Centre at St. James's University Hospital

Melanoma Family Case-Control Study Protocol

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

3700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Leeds, England, United Kingdom, LS9 7TF
        • Recruiting
        • Leeds Cancer Centre at St. James's University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Primary Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 9, 2007

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRUK-LCC-1/3/57
  • CDR0000532934 (Registry Identifier: PDQ (Physician Data Query))
  • EU-20704

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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