NCT05740111: PREPAIRD

The PREPAIRD Study: Personalized Surveillance for Early Detection of Pancreatic Cancer in High Risk Individuals

ENROLLING BY INVITATION NA Last updated 22 February 2023

What this trial tests

NA trial testing Annual surveillance in Hereditary Pancreatic Cancer in 200 participants. Enrolling by invitation.

Timeline

1 September 2022

Primary endpoint
31 December 2042

31 December 2042

Quick facts

Lead sponsor	Oslo University Hospital
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	200
Start date	1 September 2022
Primary completion	31 December 2042
Estimated completion	31 December 2042
Sites	1 location across Norway

Drugs / interventions tested

• Annual surveillance

Conditions studied

• Hereditary Pancreatic Cancer — all drugs for Hereditary Pancreatic Cancer →

Sponsor

Oslo University Hospital

Who can join

Adults 30 to 80, any sex, with Hereditary Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this national and multidisciplinary project is to establish and evaluate a personalized surveillance program (SP) for early diagnosis of pancreatic cancer (PC) and its precursors in individuals with a hereditary predisposition to the disease (High RIsk Individuals (HRI)). Patients who either carry a germline mutation in a PC susceptibility gene (CDKN2A, STK11, TP53, PRSS1), or have a strong family history of PC, will be enrolled through their genetics clinic at the university hospitals in Oslo, Bergen, Trondheim and Tromsø. Surveillance consists of annual MRI, assessment of blood glucose and lipid levels, new onset diabetes (NOD) and unintentional weight loss. Blood samples will be drawn for ctDNA-analysis (circulating tumor DNA) and the IMMrayTM PanCan-d test (a novel microarray-based diagnostic test for PC) at baseline and in those who develop lesions. The psychological burden and cost-benefit of the SP will be analyzed. The study addresses an unmet need for the care of HRI in Norway, and is expected to improve PC prognosis. It will be the first to provide evidence on the combined value of a panel of blood-borne biomarkers in surveillance, and provide morphological and molecular data on PC and (non)-neoplastic pancreatic changes in HRI.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Biomarkers for Early Detection of Pancreatic Cancer.
   Bengtsson A, Andersson R, Linders J, Gulla A, et al · · 2025 · cited 3× · PMID 40612538 · DOI 10.1159/000546584