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NCT03568630Recruiting

Blood Markers of Early Pancreas Cancer

A Longitudinal Cohort Study to Identify Clinical and Blood Markers of Early Pancreas Cancer

Source: ClinicalTrials.gov · Last updated 2 Feb 2026

Brief summary (registry, in English)

Identifying biomarkers of early pancreatic ductal adenocarcinoma (PDAC) could facilitate screening for individuals at higher than average risk and expedite the diagnosis in individuals with symptoms and substantially improve an individual's chance of surviving the disease. The investigators propose a longitudinal study of subjects at higher than average risk of PDAC in order to generate clinical data and bank serial blood specimens.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1250 (estimated)
First submitted
13 Jun 2018
Start date
26 Jul 2018
Primary completion date
31 Jul 2028
Lead sponsor
University of Nebraska
NCT number
NCT03568630

What you commit to

  • Study type: Observational
  • Planned participants: 1250
  • From 26 Jul 2018 to the primary completion date, 31 Jul 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently receiving treatment for a cancer diagnosis (excluding long-term hormonal therapy)

Other illness

  • Personal history of pancreatic ductal adenocarcinoma (PDAC)

Age

  • Pre-diabetes on metformin for ≥ 3 years

Who the study is looking for

  • Age ≥19
  • Able to provide written, informed consent
  • Able to attend an in-person study visit in Omaha, NE twice a year to collect blood samples
  • Must also meet criteria for one specific cohort. Participants who meet criteria for more than one cohort are eligible. (The intent being that potential participants must meet the criteria for at least one cohort, but are eligible if criteria are met for more than one cohort)
    • o New onset diabetes/high-risk pre-diabetes cohort: must meet one of the following criteria: New onset type 2 diabetes diagnosed within the past 3 years, defined as A1c ≥ 6.5%, fasting blood glucose \>126mg/dL confirmed on a subsequent day or as diagnosed by a physician High-risk pre-diabetes: A1c \>6.3% or A1c \>6.0% with fasting blood glucose \>110 or 2 hour oral glucose tolerance test between 140-200mg/dL, or taken metformin \<3 years
    • o Pancreatic cystic neoplasm/pancreatitis cohort: must have one of the following diagnoses: Pancreatic cystic neoplasm for which resection, endoscopic ultrasound (EUS) or serial imaging has been recommended Chronic pancreatitis as defined by cross-sectional imaging, endoscopic ultrasound, functional testing abnormalities OR as diagnosed by a gastroenterologist
    • o Inherited risk cohort: must meet one of the following criteria: Two or more blood relatives with pancreatic ductal adenocarcinoma (PDAC), includes 1st-3rd degree relatives (First - parent, sibling or child; Second - grandparent, aunt/uncle, niece/nephew, or half-sibling; Third - first cousin, great grand parent or great grandchild) One 1st degree relative with PDAC diagnosed before age 60; Germline mutation associated with a higher than average risk of PDAC, including but not limited to: Hereditary breast and ovarian cancer syndromes (BRCA1, BRCA2, PALB2) Hereditary nonpolyposis colon cancer (Lynch) syndrome (MLH1, MSH2, MSH6, PMS2) Familial adenomatous polyposis (APC) Familial atypical multiple melanoma and mole syndrome (CKDN2a, p16) Peutz-Jeghers syndrome (STK11) Ataxia-telangectasia (ATM) Juvenile polyposis syndromes (SMAD4, BMPR1A) Li Fraumeni (TP53) Cystic fibrosis and unaffected carriers (CFTR) Personal or family history which meets clinical criteria for a hereditary cancer syndrome and includes a relative with PDAC (as above)

Age in the registry: 19 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Unversity of Nebraska Medical Center
Coordinator of this site? Confirm its status
OmahaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.