Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts
Recruiting · NCT06271291 · Observational (researchers observe without assigning treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
Non-Interventional Study
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
9 locations listed across 9 US states.
- HonorHealth Research Institute - Scottsdale, Arizona, United States
- Piedmont Healthcare - Atlanta, Georgia, United States
- OSF Saint Francis Medical Center - Peoria, Illinois, United States
- The Johns Hopkins University School of Medicine - Baltimore, Maryland, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Mayo Clinic in Rochester - Rochester, Minnesota, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- Oregon Health & Science University - Portland, Oregon, United States
- University of Pittsburgh - Pittsburgh, Pennsylvania, United States