International CAPS Registry: Pancreas Cancer Cases in Surveillance Programs

Completed

• Conditions: Pancreas Cancer

• Registration Number: NCT02703545
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2016-03-03
• Study First Posted: 2016-03-09
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Elevated pancreas cancer risk cohort with pancreas cancer or dysplastic pancreas changes

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients and resected lesions with pancreatic cancer in situ (high grade dysplasia) or invasive malignancy	5 years	Prevalence of pancreatic neoplasia high risk patients who had surgery for detected lesions in screening programs

Secondary Outcome Measures

Name	Time	Method
Incidence of pancreatic in-situ and invasive malignancy after baseline screening	5 years	Proportion of patients who had surgery or biopsy for new pancreatic lesions on follow-up
Calculate survival time from point of diagnosis and treatment	5 years
Calculate all-cause and disease specific mortality	5 years
Indications for pancreas surgery	5 years	Pathology or imagining related to surgery indication
Proportion of specific types of pancreatic neoplasms by lesion type	5 years