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Sponsors and Collaborators: |
Johns Hopkins University The Lustgarten Foundation National Cancer Institute (NCI) |
Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00438906 |
The purpose of this study is to find the best and most sensitive screening modality (CT, MRI, EUS)for very small pre-cancerous pancreatic lesions and to treat these small lesions before they turn into cancer. Another purpose of this study is to search for common markers on DNA that would increase the chance of someone developing pancreatic cancer, and locate proteins in pancreatic juice that indicate tumor development.
Condition | Intervention |
Pancreatic Neoplasm Peutz-Jeghers Syndrome |
Procedure: Biopsy, Fine Needle Aspiration (FNA) Drug: Secretin (human synthetic) - ChiRhoClin |
Genetics Home Reference related topics: | Peutz-Jeghers syndrome |
MedlinePlus related topics: | Cancer Pancreatic Cancer |
ChemIDplus related topics: | Pancrelipase Ultrase Secretin |
Study Type: | Observational |
Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
Official Title: | Screening for Early Pancreatic Neoplasia |
Estimated Enrollment: | 200 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2009 |
Pancreatic cancer (PC) is the 4th leading cause of cancer death in the U.S. Because it is seldom diagnosed at an early curable stage, nearly all patients die from their disease. Early detection of PC and its precursors will save lives. In a multi-center, translational prospective controlled cohort study, we propose to screen high-risk individuals (members of familial pancreatic cancer kindreds and/or those with germline mutations of BRCA-2, p16, or STK-11), using EUS, CT, and MRI and test a panel of candidate biomarkers. Patients with suspected neoplasms will be offered surgery and the resected pancreata will be examined by an expert pathologist. Pathological results will be compared with radiologic findings and biomarker results. Our study hypothesis is that screening tests can detect early curable non-invasive pancreatic neoplasia in high risk individuals before it progresses to invasive cancer. The primary specific aim of this study is to determine the frequency of detectable pancreatic neoplasia in individuals with an inherited predisposition for pancreatic cancer. Our additional specific aims are: 1) To test the value of a newly-developed method (PANCPRO) of calculating the risk families have of developing PC so as to best target who might benefit from screening; 2a). To compare performance characteristics and reliability of the pancreatic imaging tests EUS, CT, and MRI/MRCP for the detection of early pancreatic neoplasia; 2b) To determine the prevalence of abdominal and pelvic tumors by CT and MRI in individuals carrying a germ-line BRCA2 gene mutation and patients with Peutz-Jeghers syndrome; 2c) To correlate radiologic abnormalities with histologic findings in resected pancreata; and 3). To validate a panel of candidate DNA and protein markers (CA19-9, macrophage inhibitory cytokine-1 (MIC-1), DNA hypermethylation, and KRAS gene mutations) in pancreatic juice and serum as indicators of prevalent neoplasms in high risk individuals, compared to concurrently enrolled controls.
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hilary Cosby, R.N., CGRN | 410-502-2893 | hcosby1@jhmi.edu |
United States, Maryland | |||||
Johns Hopkins Hospital | Recruiting | ||||
Baltimore, Maryland, United States, 21287 | |||||
Contact: Hilary Cosby, R.N., CGRN 410-502-2893 hcosby1@jhmi.edu | |||||
Principal Investigator: Marcia I Canto, M.D. | |||||
Principal Investigator: Michael Goggins, M.D. | |||||
Principal Investigator: Sanjay Jagannath, M.D. | |||||
Principal Investigator: Syed Ali, M.D. | |||||
Principal Investigator: Richard Schulick, M.D. | |||||
Principal Investigator: Anthony Kalloo, M.D. | |||||
Principal Investigator: Sergey Kantsevoy, M.D. | |||||
Principal Investigator: Elliot Fishman, M.D. | |||||
Principal Investigator: Karen Horton, M.D. | |||||
Principal Investigator: Jennifer Axilbund | |||||
Principal Investigator: Kieran Brune | |||||
Sub-Investigator: Constance Griffin | |||||
Principal Investigator: Anirban Maitra, M.D. | |||||
Principal Investigator: James Eshleman, M.D. | |||||
Principal Investigator: Steven Goodman, M.D. | |||||
Principal Investigator: Francis Giardiello, M.D. | |||||
Principal Investigator: Ralph Hruban, M.D. | |||||
Sub-Investigator: Hilary Cosby, RN, CGRN | |||||
Principal Investigator: Ihab Kamel, M.D. | |||||
Principal Investigator: Alison Klein, M.D. | |||||
Sub-Investigator: Emily Palmissano | |||||
Sub-Investigator: Sarah Ord | |||||
Sub-Investigator: Sara Lowther, M.S. | |||||
Sub-Investigator: Alla Guseynova, M.S. |
Johns Hopkins University |
The Lustgarten Foundation |
National Cancer Institute (NCI) |
Principal Investigator: | Marcia I. Canto, M.D. | Johns Hopkins University |
Study ID Numbers: | 3 P50CA062924-13SB |
First Received: | February 20, 2007 |
Last Updated: | April 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00438906 |
Health Authority: | United States: Food and Drug Administration |
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