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| Descriptive Information Fields | |||||
| Brief Title † | Study of Individuals and Families at High Risk for Melanoma | ||||
| Official Title † | Clinical, Laboratory And Epidemiologic Characterization Of Individuals And Families At High Risk Of Melanoma | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | |||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Hereditary Melanoma 1 and 2 (cdkn2, cdk4) Melanoma (Skin) |
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| Intervention † | 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 |
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| MEDLINE PMIDs | 16905682, 17047042, 15937071, 16172233, 15856016, 15173226, 12844286, 12853981, 12072543, 12115485, 11828258, 16618869, 16234555, 15146471, 15184262, 15529312, 12424065, 12115352 | ||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() Featured trial article  ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | |||||
| Start Date † | June 2002 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Gender | Both | ||||
| Ages | up to 95 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00045240 | ||||
| Organization ID | CDR0000256916 | ||||
| Secondary IDs †† | NCI-02-C-0211 | ||||
| Study Sponsor † | NCI - Center for Cancer Research-Medical Oncology | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | February 2007 | ||||
| First Received Date † | September 6, 2002 | ||||
| Last Updated Date | October 18, 2008 | ||||