Screening for Early Pancreatic Neoplasia
40 Years
80 Years
Both
Pancreatic Neoplasm, Peutz-Jeghers Syndrome
Trial Information
Screening for Early Pancreatic Neoplasia
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.
Inclusion Criteria:
- Persons with a verified family history of 2 or more first degree relatives with
primary site pancreatic cancer(PC), age 40-80 years old or if 1 first degree relative
also has at least 2 second degree relatives affected with PC.
- Persons with a verified BRCA2 gene mutation or FAMM/p16 gene mutation, age 40-80
years old, and family history of pancreatic cancer.
- Persons with Peutz-Jeghers Syndrome, 30-80 years old, and family history of
pancreatic cancer.
Exclusion Criteria:
- Persons with pancreatic cancer, or suspicious symptoms.
- Persons who have had pancreas specific imaging protocol performed in the past three
years.
- Persons medically unable to have an endoscopy, CT or MRI procedure
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
To determine the diagnostic yield of screening high risk patients
Outcome Description:
To determine the diagnostic yield of screening high risk patients (defined as relatives of patients with familial pancreatic cancer,patients with familial Peutz-Jeghers syndrome, and patients with germline BRCA2 and p16 mutations) for early pancreatic neoplasia using endoscopic ultrasonography, CT, and MRI/MRCP.
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Marcia I. Canto, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Johns Hopkins University
Authority:
United States: Institutional Review Board
Study ID:
3 P50CA062924-13SB
NCT ID:
NCT00438906
Start Date:
December 2006
Completion Date:
December 2009
Related Keywords:
- Pancreatic Neoplasm
- Peutz-Jeghers Syndrome
- pancreatic lesions
- pancreatic cancer
- peutz-jeghers syndrome
- BRCA 2 gene mutation
- FAMMM/p16
- Genes, BRCA2
- Neoplasms
- Pancreatic Neoplasms
- Peutz-Jeghers Syndrome
Name | Location |
|---|---|
| Johns Hopkins Hospital | Baltimore, Maryland 21287 |
