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

Recruiting

• Conditions: pancreatic cancer; cancer of the pancreas; Pancreatic ductal adenocarcinoma; 10017990; 10017991

• Registration Number: NL-OMON54674
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 700

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

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The resectability, stage distribution and survival of pancreatic cancer cases<br /><br>in the screened high risk population as compared to the general population.</p><br>

Secondary Outcome Measures

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