Clinical trial · Observational
Blood Markers of Early Pancreas Cancer
A Longitudinal Cohort Study to Identify Clinical and Blood Markers of Early Pancreas Cancer
NCT03568630CI-TRIAL-00102183recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Pancreatitis | — | UNRESOLVED | — |
| Diabetes Mellitus, Type 2 | — | UNRESOLVED | — |
| Genetic Predisposition to Disease | — | UNRESOLVED | — |
| Inherited Disease | — | UNRESOLVED | — |
| Pancreas Cyst | — | UNRESOLVED | — |
| PreDiabetes | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- New Onset Diabetes/High-Risk Prediabetes
- description
- Must meet one of the following criteria: 1. New onset type 2 diabetes diagnosed within the past 3 years, defined as Hemoglobin A1c ≥ 6.5%\*, fasting blood glucose \>126mg/dL confirmed on a subsequent day or as diagnosed by a physician 2. High-risk pre-diabetes: Hemoglobin A1c \>6.3% or A1c \>6.0% with fasting blood glucose \>110 or 2 hour oral glucose tolerance test between 140-200mg/dL; subjects who have been on metformin \<3 years are eligible
- label
- Pancreatic Cystic Neoplasm/Pancreatitis
- description
- Must meet one of the following criteria: 1. Pancreatic cystic neoplasm for which resection, endoscopic ultrasound or serial imaging has been recommended 2. Chronic pancreatitis as defined by cross-sectional imaging, endoscopic ultrasound, functional testing abnormalities OR as diagnosed by a gastroenterologist
- label
- Inherited Risk
- description
- Must meet one of the following criteria: 1. Two or more blood relatives with PDAC (includes 1st-3rd degree relatives as defined in Table 2) 2. One 1st degree relative with PDAC diagnosed before age 60 3. Germline mutation associated with a higher than average risk of PDAC including but not limited to the following: 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-telangiectasia ATM Juvenile polyposis syndromes SMAD4, BMPR1A Li Fraumeni TP53 Cystic fibrosis and unaffected carriers CFTR 4. Personal or family history which meets clinical criteria for a hereditary cancer syndrome and includes a relative with PDAC
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.