International CAPS Registry: Pancreas Cancer Cases in Surveillance Programs (CAPS Registry)

November 16, 2023 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

58

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Familial or genetic pancreas cancer risk cohorts found to have pancreas cancer or pancreas dysplasia

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Peutz-Jeghers syndrome
Familial pancreas cancer

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
Germline mutation Carrier 10 % risk
BRCA2 mutation carrier with family history of pancreas cancer or, PALB2 mutation carrier or, FAMMM (p16/CDKN2A) mutation carrier
Germline mutation carrier 5 % risk
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
PRSS1, PRSS2, CTRC gene mutations

What is the study measuring?

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Marcia I Canto, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

July 16, 2015

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimated)

March 9, 2016

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00027287

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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