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

Last updated: February 13, 2023
Sponsor: Oslo University Hospital
Overall Status: Active - Enrolling

Phase

N/A

Condition

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT05740111
387940
  • Ages 30-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Men or women with a germline mutation in CDKN2A, TP53, PRSS1 or STK11
  2. Men or women who are first degree relatives to a patient with pancreatic cancer (PC)in a family with Familial Pancreatic Cancer (FPC).

Exclusion

Exclusion Criteria: Patients undergoing active cancer treatment.

Study Design

Total Participants: 200
Study Start date:
September 01, 2022
Estimated Completion Date:
December 31, 2042

Connect with a study center

  • Oslo University Hospital

    Oslo,
    Norway

    Site Not Available

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