The PREPAIRD Study: Personalized Surveillance for Early Detection of Pancreatic Cancer in High Risk Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Annual surveillance.
- Who it may be relevant to
- Registry conditions: Hereditary Pancreatic Cancer. Basic parameters: 30 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The PREPAIRD Study: Personalized suRveillance for Early Detection and Prevention of Pancreatic cAncer in High Risk inDividuals
Overview
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.
Interventions
- Other Annual surveillance
Annual surveillance includes annual MRI and/or an assessment new onset diabetes and unintended weight loss.
Primary outcome measures
- 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. [Time frame: Up to 20 years]
- 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. [Time frame: 20 years]
Secondary outcome measures (10)
- Healthcare utilization [Time frame: 20 years]
- Quality of life of participants undergoing surveillance as assessed with the Hospital Anxiety and Depression Scale (HADS) [Time frame: 10 years]
- Costs [Time frame: Up to 20 years]
- Cost-effectiveness analysis [Time frame: Up to 20 years]
- Quality of life of participants undergoing surveillance as assessed with the Impact of Event Scale (IES) [Time frame: 10 years]
- The cancer worry of participants undergoing surveillance as assessed with the Cancer Worry Scale [Time frame: 10 years]
- The general health of participants undergoing surveillance as assessed with the General Health Questionnaire [Time frame: 10 years]
- The psychological consequences of undergoing screening for pancreatic cancer as assessed by the Psychological Consequences of Screening questionnaire [Time frame: 10 years]
- The general health of participants undergoing surveillance as assessed by the Genereal Health questionnaire [Time frame: 10 years]
- The psychological well-being of participants undergoing surveillance as assessed by the Psychological Well-being Questionnaire [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- Men or women with a germline mutation in CDKN2A, TP53, PRSS1 or STK11
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Norway · 1 center
- Oslo University Hospital — Oslo
Identifiers
NCT: NCT05740111 · 387940