The Role of Meat-borne Carcinogens in Pancreatic Cancer

Sponsor

University of Minnesota (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01092689

Collaborator

University of Arkansas (Other), Lawrence Livermore National Laboratory (Other)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cancer	Drug: PhiP	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PhIP Prior to surgery, consented subjects will ingest a capsule containing [14C]PhIP. This amount of [14C]PhIP (84 micrograms PhIP; 15.6 micro-curies) is equivalent to that in 2 very well done grilled/barbecued chicken breasts (Sinha 1995); the amount of radioactivity is equivalent to the dose received in a commercial airline flying at 30,000 ft. for 5 h (HPS 2007) or to the amount received during a typical chest x-ray.	Drug: PhiP 1 capsule of 84 micrograms; 15.6 micro-curies [14C]PhIP

Arm

Intervention/Treatment

Experimental: PhIP

Prior to surgery, consented subjects will ingest a capsule containing [14C]PhIP. This amount of [14C]PhIP (84 micrograms PhIP; 15.6 micro-curies) is equivalent to that in 2 very well done grilled/barbecued chicken breasts (Sinha 1995); the amount of radioactivity is equivalent to the dose received in a commercial airline flying at 30,000 ft. for 5 h (HPS 2007) or to the amount received during a typical chest x-ray.

Drug: PhiP

1 capsule of 84 micrograms; 15.6 micro-curies [14C]PhIP

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Quantify [14C]PhIP and [14C]PhIP metabolites in urine and plasma. [From 0 to 24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

University of Minnesota
University of Arkansas
Lawrence Livermore National Laboratory

Investigators

Principal Investigator: Kristin E Anderson, PhD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT01092689

Other Study ID Numbers:

2007NT128

First Posted:

Mar 25, 2010

Last Update Posted:

Jun 26, 2020

Last Verified:

Jun 1, 2020

Keywords provided by University of Minnesota

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Jun 26, 2020