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Trial Title:
The PREPAIRD Study: Personalized Surveillance for Early Detection of Pancreatic Cancer in High Risk Individuals
NCT ID:
NCT05740111
Condition:
Hereditary Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Surveillance
Early detection
Prevention
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Annual surveillance
Description:
Annual surveillance includes annual MRI and/or an assessment new onset diabetes and
unintended weight loss.
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.
Criteria for eligibility:
Criteria:
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 Criteria: Patients undergoing active cancer treatment.
Gender:
All
Minimum age:
30 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Oslo University Hospital
Address:
City:
Oslo
Country:
Norway
Start date:
September 1, 2022
Completion date:
December 31, 2042
Lead sponsor:
Agency:
Oslo University Hospital
Agency class:
Other
Collaborator:
Agency:
Helse Sor-Ost
Agency class:
Other
Collaborator:
Agency:
University of Oslo
Agency class:
Other
Collaborator:
Agency:
Haukeland University Hospital
Agency class:
Other
Collaborator:
Agency:
St. Olavs Hospital
Agency class:
Other
Collaborator:
Agency:
Helse Stavanger HF
Agency class:
Other
Collaborator:
Agency:
University of Bergen
Agency class:
Other
Collaborator:
Agency:
Immunovia, Inc.
Agency class:
Industry
Collaborator:
Agency:
University Hospital of North Norway
Agency class:
Other
Source:
Oslo University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05740111
