$0.00
Shopping Cart
Facebook-f Instagram
DONATE
Donate

Clinical Trial Record

Return to Clinical Trials

The Role of Meat-borne Carcinogens in Pancreatic Cancer

2012-01

2012-01

2012-01

0

Study Overview

The Role of Meat-borne Carcinogens in Pancreatic Cancer

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.

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.

  • Pancreas Cancer
  • DRUG: PhiP
  • 2007NT128

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2010-03-23  

N/A  

2020-06-24  

2010-03-23  

N/A  

2020-06-26  

2010-03-25  

N/A  

2020-06  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Basic Science

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/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 radio

DRUG: PhiP

  • 1 capsule of 84 micrograms; 15.6 micro-curies [14C]PhIP
Primary Outcome MeasuresMeasure DescriptionTime Frame
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 MeasuresMeasure DescriptionTime Frame
Quantify [14C]PhIP and [14C]PhIP metabolites in urine and plasma.From 0 to 24 hours

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • University of Arkansas
  • Lawrence Livermore National Laboratory
  • PRINCIPAL_INVESTIGATOR: Kristin E Anderson, PhD, University of Minnesota

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

NPCF Pop up

Make-A-Will Month

Snag 6508be92
Learn More
Donate Now Online
Other Ways to Donate