ACTRN12624000421538Not yet recruitingUnknown
Assess the effectiveness of the Australian Pancreatic High-RIsk ScrEening Program in identifying early-stage pancreatic cancer among high-risk individuals due to familial or genetic risk factors
Epworth HealthCare0 sites500 target enrollmentStarted: April 8, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Prevention
Eligibility Criteria
- Ages
- 18 Years to 90 Years (—)
- Sex
- All
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.
Investigators
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