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Understanding the Role of Meat-Borne Carcinogen in Pancreatic Cancer Etiology

Phase 1
18 Years
Open (Enrolling)
Pancreas Cancer

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Trial Information

Understanding the Role of Meat-Borne Carcinogen in Pancreatic Cancer Etiology

Pancreatic cancer is rapidly fatal in most cases and little is known about its causes.
Identifying and modifying risk factors can reduce mortality through prevention. Carcinogens
that form in meat cooked at high temperatures may be modifiable risk factors for pancreatic
cancer, but direct evidence is needed to demonstrate involvement in pancreas tissue. We
propose to recruit subjects scheduled for pancreatectomy as a treatment for pancreatic
cancer. These subjects will ingest a very low dose of radiolabeled PhIP, a meat-derived
carcinogen, and a small amount of resected tissue (waste) will be analyzed with highly
sensitive technology to determine if this carcinogen binds to DNA in the pancreas. We
hypothesize that the meat-derived carcinogen will bind to DNA in the pancreas. The amount of
PhIP ingested is equivalent to the amount in two very well-done barbecued chicken breasts
and the dose of radioactivity is comparable to a typical chest x-ray. This research can
increase understanding of pancreatic carcinogenesis, facilitating the design of prevention

Inclusion Criteria:

- At least 18 years old.

- Adequate hepatic function within 4 weeks of study enrollment defined as bilirubin ≤ 2
mg/dl and ALT, AST, and alkaline phosphatase ≤ 2 times the upper limit of normal.

- Females of childbearing potential or males whose partners are of child bearing
potential are required to use an effective method of contraception (i.e., a hormonal
contraceptive. intra-uterine device, diaphragm with spermicide, condom with
spermicide, or abstinence) during the study and for 4 months after PhIP

- Voluntary written informed consent (PhIP consent and Caffeine assay consent) before
performance of any study-related procedure not part of normal medical care, with the
understanding that the subject may withdraw consent at any time without prejudice to
future medical care.

Exclusion Criteria:

- CA-19-9 equal to or above 400.

- Tumor size >3.5 cm.

- Fluid in the abdomen (ascites).

- Conditions present, which, in the opinion of the surgeon, could make resection
difficult, e.g., extensive vascular involvement.

- Pregnant or lactating (for women).

- Uncontrolled cardiovascular disease; e.g. hypertension, angina, etc.

- Patients who are intolerant of a 200 mg dose of caffeine or who otherwise do not wish
to participate in the caffeine assay when consent is sought for the primary consent
will be considered refusers and will not be enrolled in the study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Quantify and characterize HCA-DNA adducts in resected human pancreatic tissue after a dietary relevant dose of PhIP, the most mass abundant HCA in charred meat.

Outcome Time Frame:

6 hours post ingestion

Safety Issue:


Principal Investigator

Kristin E Anderson, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Minnesota - Clinical and Translational Science Institute


United States: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

December 2012

Related Keywords:

  • Pancreas Cancer
  • heterocyclic amines
  • PhIP
  • Meat
  • pancreas neoplasms
  • Pancreatic Neoplasms



University of MinnesotaMinneapolis, Minnesota  55455