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International CAPS Registry: Pancreas Cancer Cases in Surveillance Programs

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02703545
Acronym
CAPS Registry
Enrollment
58
Registered
2016-03-09
Start date
2014-02-28
Completion date
2017-02-28
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Cancer

Keywords

familial pancreas cancer, pancreatic cyst

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.

Interventions

None listed

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients and resected lesions with pancreatic cancer in situ (high grade dysplasia) or invasive malignancy5 yearsPrevalence of pancreatic neoplasia high risk patients who had surgery for detected lesions in screening programs

Secondary

MeasureTime frameDescription
Indications for pancreas surgery5 yearsPathology or imagining related to surgery indication
Proportion of specific types of pancreatic neoplasms by lesion type5 years
Incidence of pancreatic in-situ and invasive malignancy after baseline screening5 yearsProportion of patients who had surgery or biopsy for new pancreatic lesions on follow-up
Calculate all-cause and disease specific mortality5 years
Calculate survival time from point of diagnosis and treatment5 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026