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NCT06271291Recruiting

Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts

Mayo Clinic

Start Date

12/12/2024

Completion Date

11/1/2029

Summary

This study evaluates individuals without pancreatic cancer, but who have been determined to be at higher-than-average lifetime risk of developing pancreatic cancer to help detect pancreatic cancer or other cancers at an earlier time when they might be more easily treated and cured.

Detailed Description

PRIMARY OBJECTIVES: 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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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: * CDKN2A/p16, Peutz-Jeghers syndrome (PJS) serine/threonine kinase 11 (STK11), Hereditary pancreatitis with confirmed protease serine 1 (PRSS1) * OR 1+ 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: * 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

Interventions

OTHER

Non-Interventional Study

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Conditions

Pancreatic Carcinoma

Locations

HonorHealth Research Institute

Scottsdale, Arizona 85258

United States

Piedmont Healthcare

Atlanta, Georgia 30309

United States

OSF Saint Francis Medical Center

Peoria, Illinois 61615

United States

The Johns Hopkins University School of Medicine

Baltimore, Maryland 21231

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Mayo Clinic in Rochester

Rochester, Minnesota 55905

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198-6805

United States

Oregon Health & Science University

Portland, Oregon 97201

United States

University of Pittsburgh

Pittsburgh, Pennsylvania 15232

United States