The Role of Meat-borne Carcinogens in Pancreatic Cancer

Pancreas Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01092689
• Other study ID #: 2007NT128
• Status: Withdrawn
• Phase: Phase 1
• Start date: January 2012
• Est. completion date: January 2012

Study information

• Verified date: June 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• PhiP
1 capsule of 84 micrograms; 15.6 micro-curies [14C]PhIP

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota	Lawrence Livermore National Laboratory, University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 hours post ingestion
Secondary	Quantify [14C]PhIP and [14C]PhIP metabolites in urine and plasma.		From 0 to 24 hours