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Completed

NCT Number: NCT02703545

International CAPS Registry: Pancreas Cancer Cases in Surveillance Programs

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Primary outcomes

  1. Proportion of patients and resected lesions with pancreatic cancer in situ (high grade dysplasia) or invasive malignancy

    Time frame: 5 years

    Prevalence of pancreatic neoplasia high risk patients who had surgery for detected lesions in screening programs

Secondary outcomes

  1. Indications for pancreas surgery

    Time frame: 5 years

    Pathology or imagining related to surgery indication

  2. Proportion of specific types of pancreatic neoplasms by lesion type

    Time frame: 5 years

  3. Incidence of pancreatic in-situ and invasive malignancy after baseline screening

    Time frame: 5 years

    Proportion of patients who had surgery or biopsy for new pancreatic lesions on follow-up

  4. Calculate all-cause and disease specific mortality

    Time frame: 5 years

  5. Calculate survival time from point of diagnosis and treatment

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Acronym: CAPS Registry

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2016
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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