International CAPS Registry: Pancreas Cancer Cases in Surveillance Programs

Pancreas Cancer Clinical Trial

— CAPS Registry  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703545
• Other study ID #: IRB00027287
• Status: Completed
• Start date: February 2014
• Est. completion date: February 2017

Study information

• Verified date: November 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

References & Publications (2)

Canto MI, Harinck F, Hruban RH, Offerhaus GJ, Poley JW, Kamel I, Nio Y, Schulick RS, Bassi C, Kluijt I, Levy MJ, Chak A, Fockens P, Goggins M, Bruno M; International Cancer of Pancreas Screening (CAPS) Consortium. International Cancer of the Pancreas Scre — View Citation

Goggins M, Overbeek KA, Brand R, Syngal S, Del Chiaro M, Bartsch DK, Bassi C, Carrato A, Farrell J, Fishman EK, Fockens P, Gress TM, van Hooft JE, Hruban RH, Kastrinos F, Klein A, Lennon AM, Lucas A, Park W, Rustgi A, Simeone D, Stoffel E, Vasen HFA, Cahe — View Citation

Outcome

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