Identifying blood markers for early pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify biomarkers of early pancreatic ductal adenocarcinoma (PDAC) to improve screening and diagnosis for individuals at higher risk. Participants will include those with a family history of pancreatic cancer, cystic pancreatic lesions, chronic pancreatitis, or new-onset diabetes. The study will involve collecting and banking serial blood specimens from these individuals over time to generate clinical data. By identifying specific blood markers, the study seeks to enhance diagnostic outcomes and potentially improve survival rates for patients diagnosed with PDAC.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)

Exclusion Criteria:

* Personal history of pancreatic ductal adenocarcinoma (PDAC)
* Currently receiving treatment for a cancer diagnosis (excluding long-term hormonal therapy)
* Pre-diabetes on metformin for ≥ 3 years

Where it's running

• Unversity of Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting

Study contacts

• Principal investigator: Kelsey A Klute, MD — University of Nebraska
• Study coordinator: Suzanne M Wessling, RN, BSN
• Email: suzanne.wessling@unmc.edu
• Phone: 402-559-1577

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.