Protocol Details

Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of melanoma

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	02-C-0211
Sponsoring Institute	National Cancer Institute (NCI)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: N/A Max Age: N/A
Referral Letter Required	No
Population Exclusion(s)	None
Special Instructions
Keywords	Genetics; Risk Factors; Natural History; melanoma Precursors; Skin Cancer
Recruitment Keyword(s)	melanoma; Skin Cancer
Condition(s)	melanoma
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Cancer Institute

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.

--Back to Top--

Eligibility

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.

--Back to Top--

Citations:

Kefford R, Genetic testing for melanoma. Lancet Oncol. 2002 Nov;3(11):653-4. No abstract available.

Goldstein AM, Genotype-phenotype relationships in U.S. melanoma-prone families with CDKN2A and CDK4 mutations. J Natl Cancer Inst. 2000 Jun 21;92(12):1006-10.

Bishop DT, Geographical variation in the penetrance of CDKN2A mutations for melanoma. J Natl Cancer Inst. 2002 Jun 19;94(12):894-903.

--Back to Top--

Contacts:

Principal Investigator	Referral Contact	For more information:
Margaret A. Tucker, M.D. National Cancer Institute (NCI) National Institutes of Health BG EPS RM 5058 MSC 7229 6120 EXECUTIVE BLVD ROCKVILLE MD 20892-7229 (301) 496-8031 tuckerp@mail.nih.gov	Margaret A. Tucker, M.D. National Cancer Institute (NCI) National Institutes of Health BG EPS RM 5058 MSC 7229 6120 EXECUTIVE BLVD ROCKVILLE MD 20892-7229 (301) 496-8031 tuckerp@mail.nih.gov	NCI Referral Office National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office 1-888-NCI-1937

Clinical Trials Number:

NCT00040352

--Back to Top--

QUESTIONS?

Contact the Patient Recruitment and Public Liaison Office for:

• Details on how to participate in a study
• Details on how to refer a patient to a study

NIH Clinical Studies Information Request

---

Contact the Office of Communications for:

• General information about the NIH Clinical Center

www.cc.nih.gov/contact.shtml

---

Contact the Department Clinical Research Informatics, (DCRI) for:

• Technical questions about Adobe Acrobat and the PDF format
• Technical questions about this web server

webmaster@cc.nih.gov