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Home > "S" Clinical Trials Conditions > Study of Skin Tumors in Tuberous Sclerosis  Study of Skin Tumors in Tuberous Sclerosis
Study of Skin Tumors in Tuberous Sclerosis
For Condition: Hereditary Neoplastic Syndrome,Tuberous Sclerosis
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: Tuberous sclerosis is a rare, hereditary disease in which patients develop multiple tumors. Although not cancerous, the tumors can affect various organs, including the heart, lungs, kidneys, skin, and central nervous system, with serious medical consequences. The severity of disease varies greatly among patients, from barely detectable to fatal. This study will investigate what causes skin tumors to develop in patients with this disease. Patients with tuberous sclerosis 18 years and older may enroll in this study. Participants will undergo a medical history and thorough skin examination by a dermatologist. Those with skin tumors will be asked to undergo biopsy (tissue removal) of up to four lesions, under a local anesthetic, for research purposes. The biopsies will all be done the same day. The tissue samples will be used for: examination of genetic changes, measurement of certain proteins and other substances, and growing in culture to study the genetics of tuberous sclerosis.
Details: Patients with tuberous sclerosis develop benign cutaneous tumors that are typically multiple in number and location. These tumors include facial angiofibromas, forehead plaques, shagreen patches, periungual fibromas, and gingival fibromas. The tumors are permanent, slow growing, and often disfiguring. The purpose of this study is to elucidate the molecular basis for these tumors. Specifically, we plan to identify the genetically altered cells in these hamartomatous lesions, and to quantify factors (e.g. cytokines) produced by these cells which induce the growth of these tumors. To accomplish this, we plan to obtain samples of these cutaneous tumors, to test tumor DNA for loss of heterozygosity, and to measure RNA and protein expression levels.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients will be those already diagnosed with TSC based on clinical criteria and/or genetic testing. The clinical features of TSC considered of major significance are: facial angiofibromas or forehead plaque, nontraumatic periungual fibromas, three or more hypomelanotic macules, shagreen patch, multiple retinal nodular hamartomas, cortical tuber, subependymal nodule, subependymal giant cell astrocytoma, cardiac rhabdomyoma, lymphangioleiomyomatosis, and renal angiomyolipoma. The minor features of TSC are: multiple randomly distributed pits in dental enamel, hamartomatous rectal polyps, bone cysts, cerebral white matter radial migration lines, gingival fibromas, nonrenal hamartoma, retinal achromic patch, "confetti" skin lesions, and multiple renal cysts. EXCLUSION CRITERIA: Inability to give informed consent. Tendency to keloid formation. Allergy to anesthetics. Bleeding abnormality.
Total Enrollment: 70
Location and Contact Information:
National Heart, Lung and Blood Institute (NHLBI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 000051; 00-H-0051
Study Start Date: January 18, 2000
Record last reviewed: December 20, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001975
Other Hereditary Neoplastic Syndrome Studies:
1. Defining the Genetic Basis for the Development of Primary Pigmented Nodular Adrenocortical Disease (PPNAD) and the Carney Complex
2. Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Cancer
3. Outcomes in Education and Counseling for HNPCC Testing
4. Clinical Manifestations and Molecular Bases of Heritable Urologic Malignant Disorders
5. Microarray Analysis for Human Genetic Disease
Related Studies:
Other Hereditary Neoplastic Syndrome Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Study of Skin Tumors in Tuberous Sclerosis
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