APRISE Program - Australian Pancreatic High-RIsk ScrEening Program for individuals who are at high risk of developing pancreatic cancer due to familial or genetic risk factors

Not Applicable

• Conditions: Pancreatic cancer; Cancer - Pancreatic

• Registration Number: ACTRN12624000421538
• Lead Sponsor: Epworth HealthCare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-08
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Individuals aged 18 to 90 years old (inclusive) without history of PDAC meeting any of the following criteria:
a)2 or more relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject and age 50+ years or 10 years younger than earliest PDAC in family at time of diagnosis.
b)2 or more affected first degree relatives with PDAC and age 50+ or 10 years younger than earliest PDAC in family.
c)BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant and 1 first or second degree relative with PDAC and age 50+ or 10 years younger than earliest PDAC in family.
d)Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant and age 40+.
e)Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant and age 35+.
f)Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis and age 40+ or 20 years after onset of pancreatitis (whichever is earlier).

Exclusion Criteria

Participants will be excluded if they are considered clinically unfit to undergo surveillance by EUS or MRI.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effectiveness of pancreatic surveillance protocols in identifying early-stage pancreatic cancer among high-risk individuals.[EUS and/or MRI Baseline and annually, for a total follow-up period of 10 years. If an abnormal finding is observed during this time, repeat EUS/MRI will be performed every 3-6 months as advised by the treating physician. Follow-up, including assessments, will be stopped upon diagnosis of cancer, or death, whichever occurs first. Should a participant be diagnosed with pancreatic cancer during the study, they will have the opportunity to consent to a separate study that is specifically designed for individuals diagnosed with pancreatic cancer as a result of surveillance. ]