An observational study in Pancreas Cancer, sponsored by Johns Hopkins University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Johns Hopkins University · Observational
Various centers around the world are currently investigating the feasibility and yield of surveillance for pancreatic cancer in high-risk individuals. Evidence is beginning to accumulate that surveillance may lead to the early detection of non-invasive precursor lesions and asymptomatic early stage cancer. Ultimately, the goal of surveillance is to reduce mortality in these high risk individuals, but before this can be confirmed many research questions need to be answered. While the numbers of high-risk individuals screened in each separate screening facility are likely too small to properly address many of these questions, pooling data comprises a sizable sample size providing unique research opportunities. The objective of this study is retrospectively review all cases of high-risk individuals participating in our pancreatic surveillance program in whom 1) a suspicious precursor lesions was detected for which a pancreatic resection was performed and 2) in whom an advanced malignant disease was diagnosed. The de-identified information will be entered into an international multicenter database registry.
The study is a retrospective review of all cases of high-risk individuals participating in our pancreatic surveillance program in whom 1) a suspicious precursor lesions was detected for which a pancreatic resection was performed and 2) in whom an advanced malignant disease was diagnosed. The de-identified information will be entered into an international multicenter database registry.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 58 is below the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Familial or genetic pancreas cancer risk cohorts found to have pancreas cancer or pancreas dysplasia
Exclusion Criteria:
at least 2 close relatives affected with pancreas cancer on same side of family 1. first degree relative and 1 second degree relative(1st degree link) or 2. first degree relatives or 1 first degree relative and 2 or more second degree relatives
BRCA2 mutation carrier with family history of pancreas cancer or, PALB2 mutation carrier or, FAMMM (p16/CDKN2A) mutation carrier
BRCA1 mutation carrier with family history of pancreas cancer or, HNPCC (Lynch Syndrome) with family history of pancreas cancer or, ATM gene mutation
PRSS1, PRSS2, CTRC gene mutations
Proportion of patients and resected lesions with pancreatic cancer in situ (high grade dysplasia) or invasive malignancy
Prevalence of pancreatic neoplasia high risk patients who had surgery for detected lesions in screening programs
Time frame: 5 years
Indications for pancreas surgery
Pathology or imagining related to surgery indication
Time frame: 5 years
Proportion of specific types of pancreatic neoplasms by lesion type
Time frame: 5 years
Incidence of pancreatic in-situ and invasive malignancy after baseline screening
Proportion of patients who had surgery or biopsy for new pancreatic lesions on follow-up
Time frame: 5 years
Calculate all-cause and disease specific mortality
Time frame: 5 years
Calculate survival time from point of diagnosis and treatment
Time frame: 5 years
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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