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Home > "H" Clinical Trials Conditions > Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer  Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
For Condition: Leiomyomatosis,Kidney Neoplasms
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will investigate what causes hereditary leiomyomatosis renal (kidney) cell cancer, or HLRCC, and how the disease is related to the development of kidney tumors. Leiomyomas are benign (non-cancerous) tumors arising from smooth muscle. HLRCC can cause various health problems. Some people develop red bumps on their skin that can be painful at times. Some women with HLRCC can develop leiomyomas of the uterus. In some families, people with HLRCC develop kidney tumors. This study will try to determine: - What gene changes (mutations) cause HLRCC; - What kind of kidney tumors develop in HLRCC and how they grow; - What the chance is that a person with HLRCC will develop a kidney tumor. People with known or suspected HLRCC and their family members of any age may be eligible for this study. This includes people in families in which one or more members has skin leiomyoma and kidney cancer; skin leiomyoma and uterine leiomyoma; multiple skin leiomyomas; or kidney cancer and uterine leiomyomas. Candidates will be screened with a physical examination, family history, and, for affected family members, a review of medical records, including pathology slides and computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants will undergo tests and procedures that may include the following: - Interviews with a cancer doctor, cancer nurses, genetic counselor and kidney surgeon; - Blood tests for: - Genetic research to identify the gene responsible for HLRCC; - Evaluation of liver, kidney, heart, pancreas, and thyroid function; - Complete blood count and clotting profile; - Pregnancy test for pre-menopausal women; - PSA test for prostate cancer in men over age 40. - CT or MRI scans; - Skin examination; - Skin biopsy (surgical removal of a small sample of skin tissue); - Cheek swab to collect cells for genetic analysis; - Medical photographs of lesions. When the tests are completed, participants will discuss the results with a doctor and possibly a genetic nurse or genetic counselor. The genetic findings will not be revealed to participants because their meaning and implications may not yet be understood. Participants may be asked to return to NIH from every 3 months to every 3 years, depending on their condition, for follow-up examinations and tests.
Details: Hereditary Leiomyomatosis and Renal Cancer syndrome (HLRCC) is a rare inherited disorder characterized by a predisposition to develop predominantly benign uterine and cutaneous leiomyomas and renal cell carcinoma. Recent studies suggest that an aggressive form of Type II papillary renal carcinoma may be associated with the HLRCC-associated uterine and cutaneous leiomyomas. The goals of this proposal are to define the types and rate of growth of renal carcinoma associated with HLRCC; to further define the risk of developing renal cancer in this hereditary cancer syndrome; to determine the clinical manifestations of HLRCC; to learn the incidence of fumarate hydratase gene mutations; to determine genotype/phenotype correlations, and to determine if other genes cause HLRCC.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA Patients with known or suspected Hereditary Leiomyomatosis and Renal Cell Cancer Syndrome and their family members of any age will be recruited from the dermatology, urology, oncology, and genetics communities worldwide. An individual from a family in which one or more family member have: Cutaneous leiomyoma and kidney cancer Cutaneous leiomyoma and uterine leiomyoma Multiple cutaneous leiomyoma Kidney cancer and uterine leiomyomata Spouses enrolled primarily for linkage analysis EXCLUSION CRITERIA Persons unable to give informed consent.
Total Enrollment: 450
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: 030066; 03-C-0066
Study Start Date: December 17, 2002
Record last reviewed: November 4, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050752
Other Kidney Neoplasms Studies:
1. Official Record of Patients Diagnosed with Lymphangioleiomyomatosis (LAM)
2. Study of the Disease Process of Lymphangioleiomyomatosis
3. Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Related Studies:
Other Kidney Neoplasms Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
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