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Sponsored by: |
Leeds Cancer Centre at St. James's University Hospital |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450593 |
RATIONALE: Identifying gene mutations and other risk factors in patients with melanoma and in families with a history of hereditary melanoma may help doctors identify persons at risk for melanoma and other types of cancer. It may also help the study of cancer in the future.
PURPOSE: This clinical trial is studying gene mutations in patients with melanoma and in families with a history of hereditary melanoma.
Condition | Intervention |
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Hereditary Melanoma 1 and 2 (cdkn2, cdk4) Melanoma (Skin) |
Procedure: gene expression analysis Procedure: gene expression profiling Procedure: laboratory biomarker analysis Procedure: mutation analysis Procedure: mutation carrier screening Procedure: study of high risk factors |
Study Type: | Observational |
Official Title: | Studies of Familial Melanoma |
Estimated Enrollment: | 5000 |
Study Start Date: | January 1989 |
Estimated Primary Completion Date: | December 2020 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a case-control, multicenter study.
Participants complete 2 questionnaires and assist in the creation and expansion of a family pedigree. Blood samples are examined for melanoma susceptibility gene mutations, including CDK4 and CDKN2A.
Participants are also examined for moles and photographed. Physical variables (e.g., skin, eye, and hair pigmentation) and sun damage (solar lentigines and freckling) are also noted.
If available, tissue samples are examined for Clark level, Breslow thickness, and frequency of mitoses. Peri-lesional skin from tumors is examined by p53 staining.
Participants are followed periodically to monitor cancer development.
Peer reviewed and funded or endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 5,000 participants will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets one of the following criteria:
Prior multiple primary melanomas
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Leeds Cancer Centre at St. James's University Hospital | Recruiting |
Leeds, England, United Kingdom, LS9 7TF | |
Contact: Julia Newton Bishop, MD 44-113-206-4668 |
Study Chair: | Julia Newton Bishop, MD | Leeds Cancer Centre at St. James's University Hospital |
Study ID Numbers: | CDR0000532941, CRUK-LCC-99/3/45, EU-20705 |
Study First Received: | March 20, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00450593 |
Health Authority: | Unspecified |
melanoma hereditary melanoma 1 and 2 (CDKN2, CDK4) recurrent melanoma stage 0 melanoma |
stage I melanoma stage II melanoma stage III melanoma stage IV melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |