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Home > "C" Clinical Trials Conditions > Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma  Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma
For Condition: Melanoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will investigate how genetic and environmental factors contribute to the development of melanoma, a type of skin cancer, and related conditions. Individuals of any age with a personal or family history of melanoma may be eligible for this study. Participants will: - Fill out one or two questionnaires about their personal and family medical history. - Provide written consent for researchers to review their medical records and pathology materials related to their care and those of deceased relatives with melanomas, tumors, cancer, or other related illnesses for whom they are the next-of-kin or legally authorized representative. - Donate a blood or cheek cell sample to be used for genetic studies. (The blood sample is collected through a needle in an arm vein. The cheek cell sample is obtained either by gently brushing the inside of the mouth with a soft brush or by swishing a tablespoon of mouthwash and then spitting it into a container.) - Undergo a skin biopsy (removal of a small piece of skin tissue) for genetic study. For this procedure, the area of skin to be removed is numbed with a local anesthetic and a 1/4-inch piece of skin is excised with a cookie cutter-like instrument. The wound is then covered with a band-aid. Participants may be asked to travel to the NIH Clinical Center for evaluation, including a medical history, physical examination, and some of the following procedures: - Full body skin examination to evaluate the type and number of moles and document any evidence of sun damage to the skin. The examination involves all the skin from the scalp to the bottoms of the feet. After the examination, a medical photographer will photograph the skin, with close-ups of skin lesions marked by the examiner. If there are parts of the skin the participant does not want examined or photographed, he or she can tell the examiner. - Blood draw of about 120 milliliters (4 ounces) or less - Skin biopsy - Cheek cell sample - X-rays, ultrasound and magnetic resonance imaging (MRI) studies to detect tumors or changes in tumors or other types of changes in specific tissues. MRI is a diagnostic test that uses strong magnetic fields and radiowaves to examine body tissues. The subject lies on a table that is moved into a large tunnel-like machine (the scanner) for about 45 minutes to 1 hour. When the tests are finished, a doctor will discuss the results with the participant and the need, if any, for clinical follow-up.
Details: This is a clinical, epidemiologic, genetic, and laboratory study of individuals and families at high risk of melanoma to investigate the genetic susceptibility to melanoma and environmental exposures which may alter risk. Families with multiple members affected by melanoma are evaluated clinically. The clinical evaluation includes a full body skin examination and photography (overview and close-up) of unusual nevi for genetic epidemiologic studies. Sun exposure and reproductive factor information is collected. Individuals with, or at high risk of, melanoma because of their personal, familial, or environmental histories are identified by healthcare worker referral or by personal inquiry. Relevant etiologic risk factor information and affection status will be documented through review of pathology specimens and medical, vital, and genealogical records. Selected individuals and family members are asked to complete questionnaires, to undergo skin examinations, and to donate biologic specimens in the search for cancer etiology and mechanisms of carcinogenesis. No therapy beyond counseling and education for melanoma prevention, risk reduction, and early detection will be given. Genetic testing for tumor susceptibility gene(s) and risk notification are offered to study participants for whom a specific mutation predictive of disease is identified in their family. Testing will only be offered when reasonable individual risk estimates can be delivered, and only to those participants who want to know their individual genetic status after appropriate education and counseling. The testing will be conducted exclusively in Clinical Laboratory Improvement Amendments (CLIA)-licensed laboratories. Genetic testing and risk notification are entirely optional and do not affect participation in other aspects of the protocol. A separate consent procedure and consent forms are used for genetic testing and risk notification related to these specific genes. Once enrolled, study participants are monitored prospectively for nevus changes or development of melanoma or other tumors, typically by means of periodic mail or telephone contact. In selected instances, subjects may return to the Clinical Center periodically for study-specific follow-up examinations. Although we do not offer specific anti-cancer therapy as part of this protocol, we provide assistance to insure that study participants who require treatment for tumor-related problems that develop during the course of the study are referred to appropriate healthcare providers. We remain available to study participants and their healthcare providers for advice and consultation related to the management of familial melanoma predisposition.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: On referral, persons of any age will be considered for inclusion in the study because of either: a family or personal medical history of melanoma of an unusual type, pattern, or number; or known or suspected factor(s) predisposing to melanoma, either genetic or congenital factors (bathing trunk nevi, dysplastic nevi), or unusual demographic features (e.g. very young age of onset, multiple melanomas, previous history of heritable retinoblastoma, Hodgkin's disease, lymphoma, or organ transplant). EXCLUSION CRITERIA: Referred individuals and families for whom reported diagnoses cannot be verified; Inability to provide informed consent.
Total Enrollment: 3000
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 020211; 02-C-0211
Study Start Date: June 20, 2002
Record last reviewed: June 3, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040352
Other Melanoma Studies:
1. Study of Karenitecin (BNP1350) to treat Malignant Melanoma
2. Decitabine in Treating Patients With Advanced Solid Tumors
3. Study of ILX651 in Patients with Inoperable Locally Advanced or Metastatic Melanoma
4. Immunization of Patients with Metastatic Melanoma Using Immunodominant Peptides from the Tyrosinase Protein, Tyrosinase Related Protein-1 (TRP1), or GP100 Protein
5. A Phase I Study of Intralesional Administration of an Adenovirus Vector Expressing the HSV-1 Thymidine Kinase Gene (AdV.RSV-TK) in Combination with Escalating Doses of Ganciclovir in Patients with Cutaneous Metastatic Malignant Melanoma
Related Studies:
Other Melanoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma
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