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Sponsored by: |
National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00062166 |
RATIONALE: Diagnostic procedures such as CT scans and MRI may improve the identification of pancreatic lesions in patients who have von Hippel-Lindau syndrome. Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer.
PURPOSE: This clinical trial is studying how well diagnostic and genetic tests work in finding pancreatic lesions in patients with Von Hippel-Lindau syndrome.
Condition | Intervention |
Neuroendocrine Carcinoma Pancreatic Cancer Von Hippel-Lindau Syndrome |
Procedure: comparative genomic hybridization Procedure: computed tomography Procedure: magnetic resonance imaging Procedure: mutation analysis Procedure: proteomic profiling Procedure: ultrasound imaging |
Genetics Home Reference related topics: | von Hippel-Lindau syndrome |
MedlinePlus related topics: | CT Scans Cancer MRI Scans Pancreatic Cancer Von Hippel-Lindau Disease |
Study Type: | Observational |
Official Title: | Evaluation of the Natural History and Management of Pancreatic Lesions Associated With Von Hippel-Lindau |
Estimated Enrollment: | 300 |
Study Start Date: | April 2003 |
OBJECTIVES:
OUTLINE: Patients undergo non-invasive imaging studies (e.g., CT scan with contrast, MRI, and/or abdominal ultrasound). Blood and urine samples are collected for laboratory analysis. Blood samples are also drawn for genetic germ line mutational analysis.
All patients are offered genetic counseling.
Patients with cystic disease of the pancreas only (no solid lesions) are followed with non-invasive imaging studies at least every 2 years.
Patients with solid lesions of the pancreas that are suspicious for pancreatic neuroendocrine tumors (PNETs) and have not reached size criteria for surgery are followed annually with CT scans and MRI.
Patients with solid lesions of the pancreas that are suspicious for PNETs and have reached size criteria for surgery or are symptomatic for PNETs may undergo surgical management. Patients with cystic disease who develop symptoms attributable to the cysts may also undergo surgical management.
In patients who undergo surgical resection, tissue is removed for further genetic analysis, including comparative genomic hybridization, cDNA microarray analysis, and tissue proteomics.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study within 5 years.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have at least 1 of the following pancreatic manifestations of VHL documented by a non-invasive imaging study:
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, 20892-1182 | |||||
Contact: Patient Recruitment 888-NCI-1937 |
Study Chair: | Steven K. Libutti, MD | NCI - Surgery Branch |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000304539, NCI-03-C-0145 |
First Received: | June 5, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00062166 |
Health Authority: | Unspecified |
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