Pancreatic Cancer Detection Consortium
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-000161
NCT ID: NCT06271291
Sponsor Protocol Number: 23-000161
About this study
The purpose of this study is to develop a cohort (biobank of biospecimens and data) of subjects without pancreatic cancer who are at high-risk for pancreatic cancer due to: a strong family history, a mutation in a known pancreatic cancer predisposition gene, or Fukuoka worrisome or high-risk pancreatic cysts. Additionally to follow the cohort subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes and to make biospecimen available to PCDC-approved projects to validate potential biomarkers for performance using nested case-control prospective designs.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Individuals without a history of PDAC meeting one or more of the following categories of criteria will be eligible for enrollment.
- PDAC Family History or PDAC-Related Genetic Mutations
- Age: 50 or older, plus at least one of the following:
- Mutation unknown or absent:
- 2+ 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; OR
- 2+ affected first degree relatives (FDR, defined as blood related parents, siblings, or children).
- Known pathogenic/likely pathogenic (P/LP) mutation in at least one of the following:
-
- CDK2NA/p16, PJS (STK11), Hereditary pancreatitis with confirmed PRSS1.
- OR 1+ FDR or SDR with PDAC and a known P/LP mutation in one or more of:
- ATM, BRCA1, BRCA2, PALB2, Lynch syndrome (MLH1, MSH2, MSH6, PMS2, EPCAM), TP53.
- High-Risk or Worrisome Pancreatic Cysts:
- 18 years of age or greater and meeting Fukuoka worrisome (FW) or Fukuoka high-risk (FHR) criteria.
- Table 1. Imaging and Clinical Features of Pancreatic Cysts Associated with Cancer Development:
- High-Risk Stigmata:
- Obstructive Jaundice in a patient with cystic lesion of the head of the pancreas;
- Enhancing mural nodule ≥ 5 mm;
- Main Pancreatic Duct ≥ 10 mm.
- Worrisome Features:
- Presence of pancreatic duct stricture, defined as focal pancreatic duct narrowing with upstream duct ≥ 6 mm;
- Cyst ≥ 3 cm;
- Enhancing mural nodule < 5 mm;
- Thickened/Enhancing cyst wall;
- Main duct size 5-9 mm;
- Pancreatitis;
- Lymphadenopathy;
- Increased CA 19-9;
- Cyst growth rate ≥ 5 mm / 2 years.
Exclusion Criteria:
- Is unable to provide informed consent.
- Has received a non-autologous bone marrow transplant or has an active hematologic malignancy (i.e., leukemia or lymphoma).
- Current or prior history of PDAC or total pancreatectomy.
- Is currently a prison inmate.
- Is not able to speak or read English.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 8/24/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available