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

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Trial Identification

Brief Title: 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 ID: NCT05740111

Interventions

Annual surveillance

Study Description

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.

Detailed Description:

Eligibility

Minimum Age: 30 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Oslo University Hospital, Oslo, , Norway

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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