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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045240 |
RATIONALE: Studying individuals and families at high risk for melanoma may help to identify other persons at risk and the genes involved in the development of melanoma.
PURPOSE: Study to identify genetic and environmental factors related to melanoma risk in individuals and families at high risk for melanoma.
Condition | Intervention |
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Hereditary Melanoma 1 and 2 (cdkn2, cdk4) Melanoma (Skin) |
Procedure: cytology specimen collection procedure Procedure: educational intervention Procedure: evaluation of cancer risk factors Procedure: gene expression profiling Procedure: mutation analysis Procedure: physiologic testing Procedure: study of high risk factors |
Study Type: | Observational |
Official Title: | Clinical, Laboratory And Epidemiologic Characterization Of Individuals And Families At High Risk Of Melanoma |
Study Start Date: | June 2002 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: One family member completes a family history questionnaire for verification of diagnosis and construction of a family pedigree. Information collected from all individuals may include skin examination and sun exposure history, overview and close-up photographs, medical history, and limited physical examination (entire skin exam for all family members and lymph node palpation for individuals with current or prior melanoma). Some individuals may also undergo an MRI and/or a skin biopsy.
Blood is collected for localizing genetic loci, identifying genes, and evaluating phenotype/genotype correlations. Each family is tested for mutations in CDKN2A and CDK4 and other potential melanoma susceptibility genes.
Each family member receives educational materials about sun protective behavior, skin self-examination, recognition of melanoma warning signs, recognition of dysplastic nevi, and changes worrisome for melanoma. Each person also receives individual risk counseling about melanoma based on personal cutaneous phenotype and position in the pedigree.
Individuals are followed every few years to document changes in their skin exam as sun exposure is decreased and to collect information from those who have undergone mole biopsies . Specific nevi are followed and photographed.
When the genetic testing results would impact clinical care recommendations, genetic testing and notification of results are offered only to participants who, after appropriate education and counseling, want to know their individual genetic status. Because of the exploratory nature of this study, results are not routinely returned to participants at this time.
A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute.
PROJECTED ACCRUAL: A total of 100 additional families will be accrued for this study within the next few years.
Ages Eligible for Study: | up to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Either of the following:
Individuals with known or suspected factor(s) predisposing to melanoma (e.g., dysplastic nevi)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Maryland | |
NCI - Division of Cancer Epidemiology and Genetics | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: Genetic Epidemiology Branch Referral Nurse 800-518-8474 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Study Chair: | Margaret A. Tucker, MD | NCI - Genetic Epidemiology Branch |
Study ID Numbers: | CDR0000256916, NCI-02-C-0211 |
Study First Received: | September 6, 2002 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00045240 |
Health Authority: | Unspecified |
melanoma hereditary melanoma 1 and 2 (CDKN2, CDK4) |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |