A Study to Detect Pancreatic Cancer Using Circulating Tumor Markers
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-011965
Sponsor Protocol Number: 18-011965
About this study
The primary purpose of this study is to select and validate candidate methylated DNA markers (MDMs) (individually and in combined panels) for the detection of pancreative ductal adenocarcinoma (PDAC). The potential complementary value of mutant KRAS and CA19-9 will also be evaluated.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 - Controls (n=425, 200 normal controls and 225 disease controls):
- Absent history of pancreatic neoplasia.
- Balanced with cases on the age, sex, and smoking history.
Exclusion Criteria - Controls (n=425, 200 normal controls and 225 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).
- Chemotherapy (e.g., as sometimes used to treat inflammatory conditions) at time of blood draw.
Exclusion Criteria - Cancer, Disease Control and Normal Control Blood:
- 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 Stool:
- 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 11/17/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available