Identifying blood markers for early pancreatic cancer
A Longitudinal Cohort Study to Identify Clinical and Blood Markers of Early Pancreas Cancer
This study is trying to find specific blood markers that can help detect early pancreatic cancer in people who are at higher risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1250 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of Nebraska Academic / other |
| Locations | 1 site (Omaha, Nebraska) |
| Trial ID | NCT03568630 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 19 and older with a family history of pancreatic cancer, cystic pancreatic lesions, chronic pancreatitis, or new-onset diabetes.
Not a fit: Patients without any of the specified risk factors for pancreatic cancer or those unable to attend in-person visits in Omaha, NE may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance early detection and improve survival rates for patients at high risk of pancreatic cancer.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for pancreatic cancer, but this specific approach is novel in its focus on high-risk populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Omaha, Nebraska
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.