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Genetic Study to Identify Gene Mutations in Participants Previously Enrolled in Clinical Trial NCI-99-C-0053 Who Have Von Hippel-Lindau Syndrome or Are at Risk for Von Hippel-Lindau Syndrome

Primary Purpose

Kidney Cancer, Von Hippel-lindau Syndrome

Status

Completed

Phase

Locations

United States

Study Type

Observational

Intervention

mutation analysis

About this trial

This is an observational trial for Kidney Cancer focused on measuring renal cell carcinoma, von Hippel-Lindau syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Prior enrollment in the von Hippel-Lindau (VHL) Syndrome Epidemiology Study NCI-99-C-0053 Meets 1 of the following criteria: Diagnosis of VHL syndrome At risk of VHL syndrome Family member of patient with VHL syndrome VHL syndrome genotype is not known PATIENT CHARACTERISTICS: Age Adult Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Sites / Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00075348

First Posted

January 9, 2004

Last Updated

March 14, 2012

Sponsor

National Institutes of Health Clinical Center (CC)

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00075348

Brief Title

Genetic Study to Identify Gene Mutations in Participants Previously Enrolled in Clinical Trial NCI-99-C-0053 Who Have Von Hippel-Lindau Syndrome or Are at Risk for Von Hippel-Lindau Syndrome

Official Title

Genetic Mutation Analysis In A VHL Population

Study Type

Observational

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

December 2003 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

National Institutes of Health Clinical Center (CC)

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

RATIONALE: The identification of gene mutations in individuals who have or are at risk for von Hippel-Lindau syndrome may allow doctors to better determine the genetic processes involved in the development of cancer. PURPOSE: This genetic study is finding gene mutations in participants with von Hippel-Lindau syndrome or who are at risk for developing von Hippel-Lindau syndrome.

Detailed Description

OBJECTIVES: Obtain laboratory identification and confirmation of research results for gene mutations in participants previously enrolled in NCI-99-C-0053 who have von Hippel-Lindau (VHL) syndrome or who are at risk for VHL syndrome. Determine genotype status in these participants. OUTLINE: Participants submit a blood or buccal sample for genetic mutation analysis. Participants may receive genetic counseling and/or the results of genetic testing, if desired. PROJECTED ACCRUAL: A maximum of 260 participants will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer, Von Hippel-lindau Syndrome

Keywords

renal cell carcinoma, von Hippel-Lindau syndrome

7. Study Design

Enrollment

260 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Genetic

Intervention Name(s)

mutation analysis

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William M. Linehan, MD

Organizational Affiliation

NCI - Urologic Oncology Branch

Official's Role

Study Chair

Facility Information:

Facility Name

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892-1182

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Genetic Study to Identify Gene Mutations in Participants Previously Enrolled in Clinical Trial NCI-99-C-0053 Who Have Von Hippel-Lindau Syndrome or Are at Risk for Von Hippel-Lindau Syndrome

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