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| Sponsor: | Johns Hopkins University |
|---|---|
| Collaborators: |
The Lustgarten Foundation National Cancer Institute (NCI) |
| Information provided by: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00438906 |
Purpose
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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Screening for Early Pancreatic Neoplasia |
approx 40 ml of blood, approx 10 ml pancreatic juice, pancreatic cells if fine needle aspirate is clinically recommended
| Enrollment: | 200 |
| Study Start Date: | December 2006 |
| 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.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
People at risk for developing pancreatic cancer related to a strong family history of pancreatic cancer or carries a known genetic mutations associated with pancreatic cancer
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| Principal Investigator: | Marcia I. Canto, M.D. | Johns Hopkins University |
More Information
| Responsible Party: | Marcia I. Canto, M.D. M.P.H>, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00438906 History of Changes |
| Other Study ID Numbers: | 3 P50CA062924-13SB |
| Study First Received: | February 20, 2007 |
| Last Updated: | January 22, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
pancreatic lesions pancreatic cancer peutz-jeghers syndrome |
BRCA 2 gene mutation FAMMM/p16 Genes, BRCA2 |
|
Neoplasms Pancreatic Neoplasms Peutz-Jeghers Syndrome Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Neoplastic Syndromes, Hereditary Intestinal Polyposis Intestinal Diseases Gastrointestinal Diseases |
Genetic Diseases, Inborn Lentigo Melanosis Hyperpigmentation Pigmentation Disorders Skin Diseases Secretin Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |