Blood Markers of Early Pancreas Cancer

Launched by UNIVERSITY OF NEBRASKA · Jun 13, 2018

Keywords

ClinConnect Summary

This clinical trial, titled "Blood Markers of Early Pancreas Cancer," is focused on finding specific markers in the blood that can help detect pancreatic cancer at an early stage. Early detection is crucial because it can significantly improve the chances of surviving the disease. The researchers are particularly interested in individuals who are at higher risk for pancreatic cancer, including those with conditions like diabetes, pancreatic cysts, or a family history of the disease.

To participate in this study, you need to be at least 19 years old and able to attend study visits in Omaha, Nebraska, twice a year to provide blood samples. It's important to note that individuals with a personal history of pancreatic cancer or those currently undergoing treatment for any type of cancer are not eligible. If you join the study, you’ll help the researchers gather important data that could lead to better screening methods and earlier diagnoses for pancreatic cancer, benefiting not just yourself but potentially many others at risk.

Gender

ALL

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