International CAPS Registry: Pancreas Cancer Cases in Surveillance Programs

NCT ID: NCT02703545

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 58 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-02-28

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.

Conditions

Pancreas Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Peutz-Jeghers syndrome

No interventions assigned to this group

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

No interventions assigned to this group

Germline mutation Carrier 10 % risk

BRCA2 mutation carrier with family history of pancreas cancer or, PALB2 mutation carrier or, FAMMM (p16/CDKN2A) mutation carrier

No interventions assigned to this group

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

No interventions assigned to this group

Hereditary pancreatitis

PRSS1, PRSS2, CTRC gene mutations

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcia I Canto, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

References

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.

Reference Type: RESULT

PMID: 23135763 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31672839 (View on PubMed)

Other Identifiers

IRB00027287

Identifier Type: -

Identifier Source: org_study_id