Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05740111
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-02-22
First Post:
2022-10-12
Brief Title:
The PREPAIRD Study Personalized Surveillance for Early Detection of Pancreatic Cancer in High Risk Individuals
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
The PREPAIRD Study Personalized suRveillance for Early Detection and Prevention of Pancreatic cAncer in High Risk inDividuals
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREPAIRD
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None