Kidney Neoplasms Clinical Trial
Official title:
Von Hippel-Lindau (VHL) Disease Genetic Epidemiology Study
Verified date | January 2020 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The Von Hippel-Lindau (VHL) Disease Genetic Epidemiology Study is a family-based case-control
study to be conducted by the National Cancer Institute. The study subjects are 603
individuals who were determined to belong to families with VHL disease confirmed through
screening under NIH protocol #89-C-0086 between 1988 and 1998. There are 293 patient
volunteers with VHL disease and 310 volunteer patients free of VHL disease, most of whom have
already had genetic testing for mutations in the VHL gene. Adults as well as children aged 13
- 17 will be included. All subjects will give informed consent prior to participation; for
minor subjects, assent will be obtained from the minor and consent from the parent/guardian.
This protocol provides the potential to benefit people with VHL disease (although not
necessarily the study subjects themselves) and possibly people with sporadic (non-hereditary)
forms of the tumors which occur in VHL disease. The risks and discomfort associated with this
study are minor.
The present protocol is a new epidemiologic component to VHL research at NIH which will
relate the expression of VHL tumors to lifestyle factors (tobacco and alcohol use; physical
activity), occupational exposures, reproductive and hormonal factors, demographic factors,
medication use, diet, and putative susceptibility genes. Information will be collected by
telephone interview and a written, self-administered diet questionnaire. A cheek cell sample
will be obtained for analyses of genetic polymorphisms. Medical records will be obtained to
document events reported by the subject at interview. Primary comparisons will be between VHL
patients with a particular manifestation and VHL patients who are free of that condition.
Additional comparisons may be made with unaffected family members who lack a mutation in the
VHL gene, as appropriate.
Status | Terminated |
Enrollment | 546 |
Est. completion date | January 9, 2020 |
Est. primary completion date | January 9, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 100 Years |
Eligibility |
- INCLUSION CRITERIA: Eligible patient volunteers are those who: 1. have been enrolled in protocol 89-C-0086; 2. are a member of a family in which at least one person has been diagnosed with VHL at NIH; and 3. are at least 13 years of age. Patient volunteers seen under protocol 89-C-0086 who have been diagnosed with VHL, are at risk of VHL, or are unaffected are all eligible for study. Additional families screened throughout the field period and meeting all eligibility criteria will also be able to participate. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Chen F, Kishida T, Yao M, Hustad T, Glavac D, Dean M, Gnarra JR, Orcutt ML, Duh FM, Glenn G, et al. Germline mutations in the von Hippel-Lindau disease tumor suppressor gene: correlations with phenotype. Hum Mutat. 1995;5(1):66-75. — View Citation
Chow WH, Gridley G, McLaughlin JK, Mandel JS, Wacholder S, Blot WJ, Niwa S, Fraumeni JF Jr. Protein intake and risk of renal cell cancer. J Natl Cancer Inst. 1994 Aug 3;86(15):1131-9. — View Citation
Neumann HP, Zbar B. Renal cysts, renal cancer and von Hippel-Lindau disease. Kidney Int. 1997 Jan;51(1):16-26. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To relate the expression of VHL tumors to lifestyle factors (tobacco & alcohol use, physical activity), occupational exposures, reproductive and hormonal factors, demographic factors, medication use, diet, and putative susceptibility gen... | Ongoing |
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