Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry conditions: Pancreatic Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Non-Interventional Study
Non-interventional study
Primary outcome measures
- Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer [Time frame: Baseline (at enrollment)]
- Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes [Time frame: Up to study completion, as defined in description]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 9 centers
- HonorHealth Research Institute — Scottsdale
- Piedmont Healthcare — Atlanta
- OSF Saint Francis Medical Center — Peoria
- The Johns Hopkins University School of Medicine — Baltimore
- Dana-Farber Cancer Institute — Boston
- Mayo Clinic in Rochester — Rochester
- University of Nebraska Medical Center — Omaha
- Oregon Health & Science University — Portland
- … and 1 more center
Identifiers
NCT: NCT06271291 · 23-000161 · U01CA210138 · U24CA274496