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Home > "D" Clinical Trials Conditions > Diagnostic and Genetic Study to Identify Pancreatic Lesions in Patients With Von Hippel-Lindau Syndrome  Diagnostic and Genetic Study to Identify Pancreatic Lesions in Patients With Von Hippel-Lindau Syndrome
Diagnostic and Genetic Study to Identify Pancreatic Lesions in Patients With Von Hippel-Lindau Syndrome
For Condition: Neuroendocrine Carcinoma,von Hippel-Lindau Syndrome,Pancreatic Cancer
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Diagnostic procedures such as CT scans and MRI may improve the identification of pancreaticlesions 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: Clinical trial to study the effectiveness of diagnostic and genetic tests in identifying pancreatic lesions in patients who have Von Hippel-Lindau syndrome.
Details: OBJECTIVES: - Identify pancreatic lesions (e.g., simple cysts, microcystic adenomas, neuroendocrine tumors, or other solid lesions of the pancreas) in patients with von Hippel-Lindau syndrome (VHL). - Follow patients with VHL and pancreatic manifestations by serial examination with non-invasive imaging studies (e.g., CT scan, MRI, and/or abdominal ultrasound). - Correlate rate of lesion growth with clinical measures of disease progression (e.g., symptoms) in patients with solid lesions of the pancreas. - Determine VHL mutation status and subtype the mutations for potential correlation with disease severity in these patients. - Obtain tissue from the pancreatic lesions of these patients for genetic analysis, including comparative genomic hybridization, tissue proteomics, and cDNA microarray analysis. - Determine the time from initial presentation with pancreatic tumors to the time that surgery is recommended in these patients. 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.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of von Hippel-Lindau syndrome (VHL) by the Urologic Oncology Branch using germ line analysis OR clinical criteria and family history - Must have at least 1 of the following pancreatic manifestations of VHL documented by a non-invasive imaging study: - Pancreatic cyst(s) - Solid lesions suspicious for microcystic adenoma(s) - Solid enhancing lesions suspicious for pancreatic neuroendocrine tumor(s) - Any other solid lesion(s) of the pancreas PATIENT CHARACTERISTICS: Age - 12 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Willing to return to the National Institutes of Health for follow-up - Willing to undergo serial non-invasive imaging PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenLibutti, Study Chair, Surgery Branch
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000304539; NCI-03-C-0145
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062166
Other Von Hippel-Lindau Syndrome Studies:
1. Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer
2. Vaccine Therapy with Tumor Specific Mutated P53 or Ras Peptides Alone or in Combination with Cellular Immunotherapy with Peptide Activated Lymphocytes (PAL Cells) Along with Subcutaneous IL-2
3. Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas
4. Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer
5. Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity
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Diagnostic and Genetic Study to Identify Pancreatic Lesions in Patients With Von Hippel-Lindau Syndrome
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