Status:
COMPLETED
Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer
Lead Sponsor:
University of Minnesota
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Study Design: This is a single institution pilot study to recruit 4 patients with operable pancreatic cancer scheduled for a pancreatectomy and 4 age/sex matched normal controls. Both groups will rec...
Detailed Description
This is not a therapeutic trial. It is an etiologic investigation of meat-borne carcinogens and possible role in pancreatic cancer.
Eligibility Criteria
Inclusion
- Cancer cases are eligible for participation if all of the following criteria are met:
- 1\. Diagnosis or suspected diagnosis of pancreatic or periampullary cancer that is deemed to be operable and for which a pancreatectomy is planned.
- At least 18 years of age.
- Adequate hepatic function within 4 weeks of study enrollment defined as:
- Bilirubin ≤ 2 mg/dl
- aspartate aminotransferase (ALT), alanine aminotransferase (AST), alkaline phosphatase ≤ 2 the upper limit of normal (ULN)
- Females of childbearing potential or males whose partners are of child bearing potential are required to use an effective method of contraception (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 2 weeks after MelQx administration.
- Voluntary written consent before performance of any study-related procedure not part of normal medical care
- Healthy controls are eligible for participation if all of the following criteria are met:
- Consider themselves generally healthy.
- At least 18 years of age
- Controls will be gender and age matched within 10 years of cases.
- Adequate hepatic function within 4 weeks of study enrollment defined as:
- Bilirubin ≤ 2 mg/dl
- ALT, AST, alkaline phosphatase ≤ 2 the upper limit of normal (ULN)
- Females of childbearing potential or males whose partners are of child bearing potential are required to use an effective method of contraception (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 2 weeks after MelQx administration.
- Voluntary written consent before performance of any study-related procedure not part of normal medical care
Exclusion
- Cancer cases are not eligible for participation if any of the following criteria are met:
- For the purposes of this study to reduce the risk of recruiting a potentially unresectable patient:
- Tumor ≥ 3 cm by scan
- CA-19-9 \> 400
- Ascites
- Pregnant or lactating
- Uncontrolled chronic conditions such as: cardiovascular disease, hypertension, angina, congestive obstructive pulmonary disease (COPD) or other conditions which may alter metabolism, other than diabetes.
- Healthy controls are not eligible for participation if any of the following criteria are met:
- Pregnant or lactating.
- Uncontrolled chronic conditions such as cardiovascular disease, hypertension, angina, COPD or conditions which may alter metabolism including diabetes.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01492907
Start Date
January 1 2012
End Date
April 1 2013
Last Update
August 22 2014
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455