Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts
NCT ID: NCT06271291
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30000 participants
OBSERVATIONAL
2024-12-12
2029-11-01
Brief Summary
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Detailed Description
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I. To develop a cohort (biobank of biospecimens and data) of subjects without pancreatic cancer who are at highrisk 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.
II. To follow the cohort subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes.
III. To make biospecimen available to PCDC-approved projects to validate potential biomarkers for performance using nested case-control prospective designs.
OUTLINE: This is an observational study.
Participants undergo blood sample collection, complete questionnaires, have their medical records reviewed and undergo pancreatic cyst fluid collection during standard of care endoscopic ultrasounds fine needle aspiration.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational
Participants undergo blood sample collection, complete questionnaires, have their medical records reviewed and undergo pancreatic cyst fluid collection during standard of care endoscopic ultrasounds fine needle aspiration.
Non-Interventional Study
Non-interventional study
Interventions
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Non-Interventional Study
Non-interventional study
Eligibility Criteria
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Inclusion Criteria
* 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:
* CDKN2A/p16, PJS (STK11), Hereditary pancreatitis with confirmed protease serine 1 (PRSS1)
* OR 1+FDR or second degree relative (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
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Ann L. Oberg, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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HonorHealth Research Institute
Scottsdale, Arizona, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Randall Brand, MD
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2024-00504
Identifier Type: REGISTRY
Identifier Source: secondary_id
23-000161
Identifier Type: OTHER
Identifier Source: secondary_id
23-000161
Identifier Type: -
Identifier Source: org_study_id
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