A Study to Detect Pancreatic Cancer Using Circulating Tumor Markers

Overview

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. If you need assistance understanding the eligibility criteria, please contact the study team.

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 had any transplants 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 and Disease Control Blood:

  • Patient has had biopsy to target organ and/or lesion within the prior 3 days before blood collection.
  • IV contrast given within 24 hours of blood collection.

Exclusion Criteria - Cancer and Disease 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.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shounak Majumder, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20460651

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