The yield of a yearly surveillance program for the early detection of pancreatic cancer and its precursor lesions in high risk individuals.

The yield of a yearly surveillance program for the early detection of pancreatic cancer and its precursor lesions in high risk individuals. - Early detection of pancreatic cancer in high-risk individuals

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54674

Enrollment

820

Registered

2013-03-07

Start date

2013-06-11

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of the pancreas Pancreatic ductal adenocarcinoma Cancer of the pancreas Pancreatic ductal adenocarcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Eligible are individuals who, after evaluation by a clinical geneticist, have an estimated >10-fold increased risk of developing pancreatic cancer, this includes: (1) Carriers of CDKN2A gene mutations (excl. mutation in exon 1b), regardless of the family history of pancreatic cancer (2) Peutz-Jeghers Syndrome patients (diagnosis based on a proven LKB1 gene mutation and/or clinical diagnosis), regardless of the family history of pancreatic cancer (3) Carriers of gene mutations in BRCA1, BRCA2, PALB2, ATM, p53, or Mismatch Repair Gene with a family history of pancreatic cancer in at least 2 family members (at least 1 PA proven, and at least 1 also a mutation carrier)

Exclusion criteria

Exclusion criteria: 1) Personal history of pancreatic cancer (2) Age younger than 18 years (3) Individuals unable to provide informed consent either due to mental retardation or language barrier (4) Severe medical illness: WHO 1 to 5 (5) PRSS1 gene mutation carrier (6) Contra-indication for EUS, due to anatomic abnormalities/surgery or patients whish. Individuals who already participate in the study with MRI-only (no EUS) will be excluded if they

Design outcomes

Primary

Measure	Time frame
The resectability, stage distribution and survival of pancreatic cancer cases in the screened high risk population as compared to the general population.	—

Secondary

Measure	Time frame
(I) The number of screen detected and resected high-grade dysplastic lesions (II) The number of intensified follow-up periods (III) The yield of EUS as a screen tool for pancreatic cancer and it*s precursor lesions: e.g. detection rate of solid and cystic lesions (VI) The number of cases that wrongfully underwent surgery, due to false positive tests (V) The natural course of development of lesions that are identified during surveillance. (IV) Identify potential biomarkers that can predict the development of high-grade dysplasia or early pancreatic cancer	—

Measure

Time frame

(I) The number of screen detected and resected high-grade dysplastic lesions (II) The number of intensified follow-up periods (III) The yield of EUS as a screen tool for pancreatic cancer and it*s precursor lesions: e.g. detection rate of solid and cystic lesions (VI) The number of cases that wrongfully underwent surgery, due to false positive tests (V) The natural course of development of lesions that are identified during surveillance. (IV) Identify potential biomarkers that can predict the development of high-grade dysplasia or early pancreatic cancer

—

Countries

Netherlands

Contacts

Public ContactD Gashi

Erasmus MC, Universitair Medisch Centrum Rotterdam

fpcstudy@erasmusmc.nl010 704 0704

Outcome results