Clinical trial NCT01092689: The Role of Meat-borne Carcinogens in Pancreatic Cancer
Official title: Understanding the Role of Meat-Borne Carcinogen in Pancreatic Cancer Etiology
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Pancreas Cancer
Keywords: heterocyclic amines
PhIP
Meat
pancreas neoplasms
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: University of Arkansas
name: Lawrence Livermore National Laboratory
First posted: 2010-03-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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 strategies.

Eligibility criteria: 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 administration.
* 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.

Primary outcomes:
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.
timeFrame: 6 hours post ingestion
Secondary outcomes:
measure: Quantify [14C]PhIP and [14C]PhIP metabolites in urine and plasma.
timeFrame: From 0 to 24 hours
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Kristin E Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References: