Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer

Completed · Phase 1

Conditions studied: Pancreatic Cancer

In brief

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 receive a single oral dose of radiolabeled MelQx followed by serial blood draws over an 8 hour period and urine collections over a 24 hour period. In addition, normal pancreatic tissue and normal small bowel tissue will be collected by Tissue Procurement from resected (waste) tissue at the time of pancreatectomy on the 4 pancreatic cancer patients.

Key facts

Study ID

NCT01492907

Run by

University of Minnesota

People needed

8

Starts

2012-01-01

Expected to finish

2013-04-01

Last updated by the study team

2014-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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