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Tier 1 for Pancreatic Cancer
N/A
Recruiting
Led By Shounak Majumder, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Study Summary
This study aims to facilitate discovery and validation of tests for early detection in subjects at high risk for pancreatic ductal adenocarcinoma (PDAC) and to facilitate the use of state-of-the-art machine learning-based algorithms that utilize databases and images with the purpose of identifying early stages of pancreatic cancer, as well as people at high-risk.The study also aims to provide a platform for development of an interventional protocol for early detection of PDAC.
Eligible Conditions
- Pancreatic Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Collection of biospecimen samples (blood and pancreatic juice)
Collection of radiology images and videos
Trial Design
2Treatment groups
Experimental Treatment
Group I: Tier 2Experimental Treatment3 Interventions
Individual with family history of PDAC in only one first degree relative (FDR); age ≥50 or 10 years younger than the affected first degree relative
OR known BRCA2, BRCA1, PALB2, ATM, MLH1, MSH2, or MSH6 gene mutation; age > 45 who do not meet tier 1 criteria.
Group II: Tier 1Experimental Treatment2 Interventions
Participants with Peutz-Jeghers syndrome and/or carriers of a germline CDKN2A mutation and/or hereditary pancreatitis with PRSS1 mutation and clinical history of pancreatitis(age ≥40 or 10 years younger than youngest affected blood relative)
Carriers of a germline BRCA2, BRCA1, PALB2, ATM, MLH1, MSH2, or MSH6 gene mutation with at least one affected first-degree blood relative (age ≥45 or 10 years younger than youngest affected blood relative)
At least one first-degree relative (FDR) with pancreatic cancer who in turn also has a first-degree relative with pancreatic cancer and/or at least two affected blood relatives on the same side of the family, of whom at least one is an FDR to the individual and/or at least three affected relatives on the same side of the family, of whom at least one is an FDR to the individual(age ≥50 or 10 years younger than youngest affected blood relative)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~1370
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,208 Previous Clinical Trials
3,762,050 Total Patients Enrolled
Shounak Majumder, M.D.Principal InvestigatorMayo Clinic in Rochester
3 Previous Clinical Trials
26,000 Total Patients Enrolled
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