|
Study of Brain and Spinal Cord Tumor Growth and Cyst Development in Patients with von Hippel Lindau Disease Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Study of Brain and Spinal Cord Tumor Growth and Cyst Development in Patients with von Hippel Lindau Disease conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Study of Brain and Spinal Cord Tumor Growth and Cyst Development in Patients with von Hippel Lindau Disease Clinical research trials and Study of Brain and Spinal Cord Tumor Growth and Cyst Development in Patients with von Hippel Lindau Disease medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Study of Brain and Spinal Cord Tumor Growth and Cyst Development in Patients with von Hippel Lindau Disease. Study of Brain and Spinal Cord Tumor Growth and Cyst Development in Patients with von Hippel Lindau Disease Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Study of Brain and Spinal Cord Tumor Growth and Cyst Development in Patients with von Hippel Lindau Disease clinical trial. Participants frequently get the best healthcare available for their Study of Brain and Spinal Cord Tumor Growth and Cyst Development in Patients with von Hippel Lindau Disease condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Study of Brain and Spinal Cord Tumor Growth and Cyst Development in Patients with von Hippel Lindau Disease  Study of Brain and Spinal Cord Tumor Growth and Cyst Development in Patients with von Hippel Lindau Disease
Study of Brain and Spinal Cord Tumor Growth and Cyst Development in Patients with von Hippel Lindau Disease
For Condition: Hemangioblastoma,Hippel Lindau Disease
Status: Recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: The purpose of this study is to learn more about the growth of brain and spinal cord tumors and cysts that develop in association with them in patients with von Hippel-Lindau disease. It will examine how fast the tumors grow and try to determine what factors (for example, puberty , pregnancy, menopause, blood proteins, etc.) affect their growth. Patients between the ages of 8 and 75 years who are enrolled in NIH's study of von Hippel-Lindau disease may be eligible for this 5-year study. Participants will have magnetic resonance imaging (MRI) of the brain and spinal cord and a thorough neurological history and examination at the start of the study. A blood sample will be taken for analysis of factors (hormones or other proteins) that may predict tumor growth. Follow-up clinic visits every 6 months will include a physical and neurological examination, blood tests, and MRI scans of the brain and spine. If symptoms or tumor growth requires more frequent follow-up, scans will be done at 3-month intervals. Surgical removal of brain and spinal cord tumors is currently the treatment of choice when these lesions cause neurological problems. A better understanding of which tumors are likely to grow and which will remain stable may help guide physicians in treatment decisions and avoid unnecessary procedures.
Details: Hemangioblastomas of the cerebellum, brainstem and spinal cord are frequent tumors in patients with von Hippel-Lindau disease. Rarely, these lesions also affect the cerebrum. Patients often have multiple lesions, many of which are associated with cysts or syrinx. The current treatment for symptomatic lesions is surgical resection. Focused radiation is also being used in selected cases in an attempt to provide tumor control. The natural history of CNS lesions in patients with VHL has not been addressed in a prospective study. It is not clear at which point these lesions will begin to grow, or develop cysts in the cerebellum or syrinx in the spinal cord, and systemic factors that influence tumor growth have not been identified. By identifying factors that predict or influence tumor progression or cyst development, we can more accurately recommend surgical or medical intervention at appropriate times and avoid unnecessary treatment for stable lesions. This study will collect prospective radiological and clinical data on growth of the CNS hemangioblastomas and associated cysts. We will also prospectively collect information on systemic processes that may influence tumor progression, such as puberty, menopause, pregnancy, effects of hormone therapy, tumor load, serum VEGF levels, hemoglobin/hematocrit levels, and erythropoietin.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients will be recruited from the NIH von Hippel-Lindau (VHL) clinic at the National Institutes of Health (NIH). All patients will have the diagnosis of von Hippel-Lindau disease confirmed using existing established criteria and meet the following requirements: 1. Consenting men and women between the ages of 18 and 75, inclusive. 2. Males and females under age of 18 whose parents/guardians can provide permission. 3. Presence of one or more cerebral, cerebellar or spinal cord hemangioblastomas on screening MRI. 4. Provide written informed consent prior to participation in the trial. 5. Karnofsky Performance Scale Score greater than or equal to 60. 6. Capacity to undergo MRI scanning. EXCLUSION CRITERIA: 1. Clinically unstable condition. 2. Karnofsky Performance Scale Score less than or equal to 60. 3. Being treated by any chemotherapy, immunotherapy, or steroids. 4. Allergy to CT or MRI contrast agents. Contraindication to MR scanning such as surgery that involves metal clips or wires which might be expected to cause tissue damage or produce image artifacts. Examples include: 1. Aneurysm clips, 2. Implanted neural stimulator, 3. Implanted cardiac pacemaker or autodefibrillator 4. Cochlear implant, 5. Ocular foreign body (e.g. metal shavings), 6. Insulin pump. Potential Exclusion Criteria Pregnancy
Total Enrollment: 200
Location and Contact Information:
National Institute of Neurological Disorders and Stroke (NINDS) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 000140; 00-N-0140
Study Start Date: June 4, 2000
Record last reviewed: May 22, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005902
Other Hippel Lindau Disease Studies:
1. Von Hippel-Lindau Disease Genetic Epidemiology Study
2. Clinical Manifestations and Molecular Bases of Heritable Urologic Malignant Disorders
3. Study of Brain and Spinal Cord Tumor Growth and Cyst Development in Patients with von Hippel Lindau Disease
Related Studies:
Other Hippel Lindau Disease Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Study of Brain and Spinal Cord Tumor Growth and Cyst Development in Patients with von Hippel Lindau Disease
|
|
|
|
|
|
|
|
