Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00438906
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2007-02-20
Brief Title:
Cancer of the Pancreas Screening Study CAPS 3
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Screening for Early Pancreatic Neoplasia
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPS 3
Brief Summary:
The purpose of this study is to find the best and most sensitive screening modality CT MRI EUSfor 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
Detailed Description:
Pancreatic cancer PC is the 4th leading cause of cancer death in the US 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 andor 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 MRIMRCP 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None