International CAPS Registry: Pancreas Cancer Cases in Surveillance Programs

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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International CAPS Registry: Operated Cases and Cases With Advanced Disease Among High-risk Individuals Participating in a Pancreatic Cancer Surveillance Program; a Case-control Study

Conditions
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Pancreas Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elevated pancreas cancer risk cohort with pancreas cancer or dysplastic pancreas changes Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Peutz-Jeghers syndrome<br> | |
| Familial pancreas cancer<br>at least 2 close relatives affected with pancreas cancer on same side of family first degree relative and 1 second degree relative(1st degree link) or first degree relatives or 1 first degree relative and 2 or more second degree relatives | |
| Germline mutation Carrier 10 % risk<br>BRCA2 mutation carrier with family history of pancreas cancer or, PALB2 mutation carrier or, FAMMM (p16/CDKN2A) mutation carrier | |
| Germline mutation carrier 5 % risk<br>BRCA1 mutation carrier with family history of pancreas cancer or, HNPCC (Lynch Syndrome) with family history of pancreas cancer or, ATM gene mutation | |
| Hereditary pancreatitis<br>PRSS1, PRSS2, CTRC gene mutations | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indications for pancreas surgery | Pathology or imagining related to surgery indication | 5 years | 
| Proportion of specific types of pancreatic neoplasms by lesion type |  | 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 | 5 years | 
| Calculate all-cause and disease specific mortality |  | 5 years | 
| Calculate survival time from point of diagnosis and treatment |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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familial pancreas cancer, pancreatic cyst