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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00055627 |
RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer and may help doctors identify patients who are at risk for cancer.
PURPOSE: This clinical trial is studying cancer risk and gene identification in patients and families with hereditary leiomyomatosis and renal cell cancer syndrome (HLRCC).
Condition | Intervention |
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Precancerous/Nonmalignant Condition |
Genetic: DNA ploidy analysis Genetic: cytogenetic analysis Genetic: genetic linkage analysis Genetic: microarray analysis Genetic: mutation analysis Other: medical chart review |
Study Type: | Observational |
Official Title: | Hereditary Leiomyomatosis Renal Cell Cancer (HLRCC): Identification Of The Disease Gene And Characterization of The Predisposition To Renal Cancer |
Estimated Enrollment: | 120 |
Study Start Date: | December 2002 |
OBJECTIVES:
OUTLINE: Detailed family and medical histories are obtained from participants. Participants then undergo one or more of the following: physical examination, blood draw, imaging studies, and karyotypic analysis.
Blood or buccal smears are examined by linkage or DNA analysis and other genetic studies.
Participants may receive an explanation of study findings, appropriate counseling about their own status, and recommendations for follow-up/treatment. Participants may receive DNA results from analysis of their fumarate hydratase gene.
Some participants with indeterminate renal lesions are followed every 3-36 months, depending on the characteristics (e.g., size and/or growth) of the lesion.
PROJECTED ACCRUAL: A total of 90-120 participants will be accrued for this study within 3 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patients with known or suspected hereditary leiomyomatosis and renal cell cancer (HLRCC) syndrome and their family members
One or more family members must have 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: Patient Recruitment 888-NCI-1937 |
Study Chair: | William M. Linehan, MD | NCI - Urologic Oncology Branch |
Study ID Numbers: | CDR0000269913, NCI-03-C-0066 |
Study First Received: | March 6, 2003 |
Last Updated: | July 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00055627 History of Changes |
Health Authority: | Unspecified |
hereditary leiomyomatosis and renal cell cancer |
Urinary Tract Neoplasm Kidney Cancer Myofibroma Leiomyomatosis and Renal Cell Cancer, Hereditary Precancerous Conditions Leiomyomatosis Disease Susceptibility Urogenital Neoplasms Urologic Neoplasms Leiomyoma |
Carcinoma Neoplasms, Connective and Soft Tissue Renal Cancer Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Genetic Predisposition to Disease Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms, Muscle Tissue Neoplasms by Histologic Type Precancerous Conditions Leiomyomatosis Urogenital Neoplasms Urologic Neoplasms Leiomyoma Carcinoma Neoplasms, Connective and Soft Tissue |
Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |