Thinking of joining a study?

Register your interest

Become a volunteer?

NCT03568630 | RECRUITING | Diabetes Mellitus, Type 2

Blood Markers of Early Pancreas Cancer
Sponsor:

University of Nebraska

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.

Condition or disease

Diabetes Mellitus, Type 2

PreDiabetes

Pancreas Cyst

Chronic Pancreatitis

Genetic Predisposition to Disease

Inherited Disease

Detailed Description:

Patients diagnosed with pancreatic ductal adenocarcinoma (PDAC) have only an 10% chance of surviving 5 years after diagnosis. Most PDAC is advanced and not amenable to curative therapies at the time of diagnosis, owing to lack of symptoms in early disease, nonspecific symptoms when they do develop resulting in a delay in diagnosis. Identifying biomarkers of early 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 participants at higher than average risk of PDAC in order to generate clinical data and bank serial blood specimens. Participants will include individuals with family history of pancreas cancer, individuals with cystic pancreas lesions or chronic pancreatitis, and individuals with new-onset diabetes. Identifying specific biomarkers - blood markers and/or a clinical "prodrome" - in participants who go on to develop PDAC could improve the diagnostic approach outcomes for patients diagnosed with PDAC.

Study Type : OBSERVATIONAL
Estimated Enrollment : 1250 participants
Official Title : A Longitudinal Cohort Study to Identify Clinical and Blood Markers of Early Pancreas Cancer
Actual Study Start Date : 2018-07-26
Estimated Primary Completion Date : 2028-07
Estimated Study Completion Date : 2028-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
Blood Markers of Early Pancreas Cancer

Location Details

NCT03568630

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Nebraska

Unversity of Nebraska Medical Center

Omaha, Nebraska, United States, 68198