International CAPS Registry: Pancreas Cancer Cases in Surveillance Programs

NCT02703545 | Completed

• 1 other identifier: IRB00027287
• Study Type: observational
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreas Cancer

Keywords

familial pancreas cancer; pancreatic cyst

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Indications for pancreas surgery

  5 years

• Proportion of specific types of pancreatic neoplasms by lesion type

  5 years

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

  5 years

• Calculate all-cause and disease specific mortality

  5 years

• Calculate survival time from point of diagnosis and treatment

  5 years

Study Arms (5)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Related 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 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.

  PMID: 23135763 RESULT

• 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.

  PMID: 31672839 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Cyst

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Cysts

Study Officials

• Marcia I Canto, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: March 9, 2016
• Study Start: February 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: November 18, 2023

Record last verified: 2023-11