Clinical Trials

Inclusion Criteria - Cases (n=225):

• Biopsy proven treatment-naïve primary PDAC.
• Pancreatic mass on imaging suspicious for PDAC.

Exclusion Criteria - Cases (n=225):

• Patient has had surgery to completely remove current target pathology prior to initial blood collection
• Patient has known primary cancer outside of the pancreas within the last 5 years prior to initial blood collection OR a documented cancer outside of the pancreas within 3 years after collection (not including basal cell or squamous cell skin cancers).
• Target pathology is a recurrence of previously treated pancreatic cancer
• Patient has received chemotherapy class drugs in the 5 years prior to initial blood collection.
• Patient has had any prior therapeutic radiation to upper abdomen prior to initial blood collection.
• Patient has other histologic variants of pancreatic cancer (neuroendocrine, adenosquamous, hepatoid etc.).
• Patient has past history of other histologic variants of pancreatic cancer (neuroendocrine, adenosquamous).

Inclusion Criteria - Disease Controls (n=25, 200 normal controls and 425 disease controls):

• Absent history of pancreatic neoplasia
• Balanced with cases on the age, sex, and smoking history.

Exclusion Criteria - Disease Controls:

• Known or prior history of pancreatic neoplasia (malignant).
• Prior history of any cancer (except non-melanoma skin cancer) in past 5 years OR a documented cancer outside of the pancreas within 3 years after blood collection (not including basal cell or squamous cell skin cancers).

Inclusion Criteria - Normal Control:

• Absent history of pancreatic neoplasia
• Balanced with cases on the age, sex, and smoking history.
• Patient does not have any known pancreatic disease.

Exclusion Criteria - Normal Control:

• Known or prior history of pancreatic neoplasia (malignant).
• Prior history of any cancer (except non-melanoma skin cancer) in past 5 years OR a documented cancer outside of the pancreas within 3 years after blood collection (not including basal cell or squamous cell skin cancers).
• Chemotherapy (e.g., as sometimes used to treat inflammatory conditions) at time of blood draw.
• Patient has suspected upper aerodigestive neoplastic disease or ampullary or biliary stricture.
• Patient known or suspected hepatobiliary inflammatory conditions.

Exclusion Criteria - Cancer, Disease Control and Normal Control Blood Exclusions:

• Patient has had biopsy to target organ and/or lesion within the prior 3 days before blood collection.

Exclusion Criteria - Cancer, Disease Control and Normal Control Stoo Exclusions:

• Bowel prep < 7 days prior to stool collection
• Enteric barium studies within the prior 7 days before stool collection.
• Oral contrast given within 7 days of stool collection.
• Removal of more than 50% of colon or presence of ileostomy.
• Enteral feeds or TPN.
• Diagnosis of inflammatory bowel disease.

Eligibility last updated 2/16/22. Questions regarding updates should be directed to the study team contact.