Clinical trial NCT05740111: The PREPAIRD Study: Personalized Surveillance for Early Detection of Pancreatic Cancer in High Risk Individuals
Official title: The PREPAIRD Study: Personalized suRveillance for Early Detection and Prevention of Pancreatic cAncer in High Risk inDividuals
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hereditary Pancreatic Cancer
Keywords: Surveillance
Early detection
Prevention
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Sor-Ost
name: University of Oslo
name: Haukeland University Hospital
name: St. Olavs Hospital
name: Helse Stavanger HF
name: University of Bergen
name: Immunovia, Inc.
name: University Hospital of North Norway
First posted: 2023-02-22
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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 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.

Primary outcomes:
measure: Prognosis of pancreatic cancer in patients diagnosed through the surveillance programme compared to prognosis in unscreened individuals as reported to the Cancer Registry of Norway.
timeFrame: Up to 20 years
measure: Number of resectable cancers detected in patients diagnosed through the surveillance programme compared to the unscreened individuals as reported to the Cancer Registry of Norway.
timeFrame: 20 years
Secondary outcomes:
measure: Healthcare utilization
timeFrame: 20 years
measure: Quality of life of participants undergoing surveillance as assessed with the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 10 years
measure: Costs
timeFrame: Up to 20 years
measure: Cost-effectiveness analysis
timeFrame: Up to 20 years
measure: Quality of life of participants undergoing surveillance as assessed with the Impact of Event Scale (IES)
timeFrame: 10 years
measure: The cancer worry of participants undergoing surveillance as assessed with the Cancer Worry Scale
timeFrame: 10 years
measure: The general health of participants undergoing surveillance as assessed with the General Health Questionnaire
timeFrame: 10 years
measure: The psychological consequences of undergoing screening for pancreatic cancer as assessed by the Psychological Consequences of Screening questionnaire
timeFrame: 10 years
measure: The general health of participants undergoing surveillance as assessed by the Genereal Health questionnaire
timeFrame: 10 years
measure: The psychological well-being of participants undergoing surveillance as assessed by the Psychological Well-being Questionnaire
timeFrame: 10 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References: