Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001803
Status:
TERMINATED
Last Update Posted:
2020-01-13
First Post:
1999-11-03
Brief Title:
Von Hippel-Lindau Disease Genetic Epidemiology Study
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Von Hippel-Lindau VHL Disease Genetic Epidemiology Study
Status:
TERMINATED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IRB approval lapsed and PI has not responded to requests to submit CR
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 parentguardian 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
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
Detailed Description:
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 parentguardian 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-C-0053 | None | None | None |