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

Summary

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.

Conditions

• Hereditary Pancreatic Cancer

Interventions

OTHER

Annual surveillance

Annual surveillance includes annual MRI and/or an assessment new onset diabetes and unintended weight loss.

Sponsors & Collaborators

• Helse Sor-Ost

  collaborator OTHER_GOV

• University of Oslo

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• University of Bergen

  collaborator OTHER

• Immunovia, Inc.

  collaborator INDUSTRY

• University Hospital of North Norway

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

30 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2042-12-31

Completion

2042-12-31

Countries

• Norway

Study Locations