Study of Families With Melanoma | Recruiting
Study of Families With Melanoma | Recruiting
Study of Families With Melanoma

Trial Source

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Medical Conditions
  • Melanoma (Skin)
Unfortunately contact details are not available for this trial.
Primary Contact Details
Recruiting
Recruitment Status
NCT00445783
Primary Trial ID Number

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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.
Research Details
  • 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.
Phase
N/A
Study Design
N/A
Study Type
Observational
Intervention
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 Arm Groups : , , , , , ,

Intervention Type
See Interventions above
Primary Outcome Measures
    Lifestyle factors governing relapse from melanoma; null; Genes governing relapse from melanoma; null; Sun exposure and genes that cause melanoma; null; Unusual moles related to sun exposure and genes that cause melanoma; null
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Sorry, this information is not available
Number of Participants
3700
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
St. James University Hospital, Department of Neurology
Leeds
LS9 7TF
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Melanoma Family Case-Control Study Protocol
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CRUK-LCC-1/3/57
Sponsor(s)
Leeds Cancer Centre at St. James's University Hospital
Key Dates

Recruitment Start Date

Jul 2000

Recruitment End Date

Dec 2020

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

07 Mar 2007

Date updated in source

09 Aug 2013