| NCT ID | NCT03568630 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nebraska |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,250 participants |
| Start Date | 2018-07-26 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,250 participants in total. It began in 2018-07-26 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Kelsey A Klute, MD
PRINCIPAL INVESTIGATOR
University of Nebraska
Frequently Asked Questions
Who can join the NCT03568630 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03568630 currently recruiting?
Yes, NCT03568630 is actively recruiting participants. Contact the research team at suzanne.wessling@unmc.edu for enrollment information.
Where is the NCT03568630 trial being conducted?
This trial is being conducted at Omaha, United States.
Who is sponsoring the NCT03568630 clinical trial?
NCT03568630 is sponsored by University of Nebraska. The principal investigator is Kelsey A Klute, MD at University of Nebraska. The trial plans to enroll 1,250 participants.
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