Cancer of the Pancreas Screening Study (CAPS 3)
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 8/24/2018 |
| Start Date: | December 2006 |
| End Date: | December 2009 |
Screening for Early Pancreatic Neoplasia
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.
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.
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.
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
We found this trial at
1
site
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
Click here to add this to my saved trials
