Clinical trial NCT02703545: International CAPS Registry: Pancreas Cancer Cases in Surveillance Programs
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Cancer
Keywords: familial pancreas cancer
pancreatic cyst
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Familial or genetic pancreas cancer risk cohorts found to have pancreas cancer or pancreas dysplasia

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Primary outcomes:
measure: Proportion of patients and resected lesions with pancreatic cancer in situ (high grade dysplasia) or invasive malignancy
timeFrame: 5 years
Secondary outcomes:
measure: Indications for pancreas surgery
timeFrame: 5 years
measure: Proportion of specific types of pancreatic neoplasms by lesion type
timeFrame: 5 years
measure: Incidence of pancreatic in-situ and invasive malignancy after baseline screening
timeFrame: 5 years
measure: Calculate all-cause and disease specific mortality
timeFrame: 5 years
measure: Calculate survival time from point of diagnosis and treatment
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Marcia I Canto, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Screening (CAPS) Consortium summit on the management of patients with increased risk for familial pancreatic cancer. Gut. 2013 Mar;62(3):339-47. doi: 10.1136/gutjnl-2012-303108. Epub 2012 Nov 7.
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, Cahen DL, Canto MI, Bruno M; International Cancer of the Pancreas Screening (CAPS) consortium. Management of patients with increased risk for familial pancreatic cancer: updated recommendations from the International Cancer of the Pancreas Screening (CAPS) Consortium. Gut. 2020 Jan;69(1):7-17. doi: 10.1136/gutjnl-2019-319352. Epub 2019 Oct 31.