Back to resultsThe Role of Meat-borne Carcinogens in Pancreatic Cancer
Primary Purpose
Pancreas Cancer
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PhiP
Sponsored by
About this trial
This is an interventional basic science trial for Pancreas Cancer focused on measuring heterocyclic amines, PhIP, Meat, pancreas neoplasms
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.
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PhIP
Arm Description
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.
Outcomes
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.
Secondary Outcome Measures
Quantify [14C]PhIP and [14C]PhIP metabolites in urine and plasma.
Full Information
NCT ID
NCT01092689
First Posted
March 23, 2010
Last Updated
June 24, 2020
Sponsor
University of Minnesota
Collaborators
University of Arkansas, Lawrence Livermore National Laboratory
1. Study Identification
Unique Protocol Identification Number
NCT01092689
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Needed New IND per FDA
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
University of Arkansas, Lawrence Livermore National Laboratory
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer
Keywords
heterocyclic amines, PhIP, Meat, pancreas neoplasms
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PhIP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
PhiP
Intervention Description
1 capsule of 84 micrograms; 15.6 micro-curies [14C]PhIP
Primary Outcome Measure Information:
Title
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.
Time Frame
6 hours post ingestion
Secondary Outcome Measure Information:
Title
Quantify [14C]PhIP and [14C]PhIP metabolites in urine and plasma.
Time Frame
From 0 to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin E Anderson, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Role of Meat-borne Carcinogens in Pancreatic Cancer
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