Relationship of Ochratoxin A to Upper Urologic Cancers

Brief Title

Relationship of Ochratoxin A to Upper Urologic Cancers

Official Title

The Relationship of Ochratoxin A to Upper Tract TCC Malignancies, Testicular Cancer, and Renal Cell Cancer

Brief Summary

      This pilot study will explore the relationship of Ochratoxin A (OTA) levels in patients with
      upper tract transitional cell (TCC), renal cell, and testicular cancers by measuring levels
      of OTA in serum and tumor samples. Dietary exposure will also be analyzed.

Detailed Description

Ochratoxin A (OTA, a ubiquitous mycotoxin) is a common food contaminant that enters the food
chain from plants such as cereals. OTA can be inhaled or ingested and livestock and humans
feeding on OTA contaminated food have been found to have detectable levels of this chemical
in their sera, liver, and kidneys.

There is risk for occupational and environmental exposure to OTA. Thus, exposure to this
mycotoxin may be a poorly recognized problem in our society. OTA has been classified as a
group 2b possible carcinogen. Exposure to OTA has been implicated in teratogenesis (fetal
malformation), nephrotoxicity, gonadotoxicity and carcinogenesis. The mechanisms for these
effects of OTA have not been fully explained. There is an increasing incidence of testis
cancer in Western societies combined with the increasing OTA exposures being reported. As
well as studying the relationship of OTA to TCC initially, we also plan to examine a possible
relationship between OTA and testicular cancer as well as renal cell carcinoma (RCC). To
date, very little research into the effects of mycotoxins in humans has been performed. We
plan to apply proven techniques of serum analysis using:

1. ELISA or Enzyme Linked Immuno-absorbent Assay which is used to measure the presence of
an antibody or antigen in the bloodstream

2. Immunohistochemistry (pathological analysis from resected tumors)

3. High -pressure liquid chromatography (HPLC) of tumor tissue to investigate the role of
OTA in human genitourinary cancers. A group of subjects without cancer will be used as a
control group.

Study Type

Observational

Condition

Transitional Cell Carcinoma

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

Start Date

September 2005

Completion Date

April 2007

Primary Completion Date

April 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Study Group

               1. Informed consent

               2. Must have resectable non-metastatic upper tract transitional cell carcinoma,
                  renal cell carcinoma, or testicular carcinoma.

               3. Willingness to be followed for survival data.

          -  Control Group

               1. Informed consent

               2. No history of carcinoma

        Exclusion Criteria:

          1. Metastatic upper tract transitional cell carcinoma, renal cell carcinoma, or
             testicular carcinoma.

          2. Any other ongoing or previous malignancy other than basal or squamous cell skin
             cancer.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Stephen Pautler, MD, FRCSC, ,

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT00216801

Organization ID

R-05-082

Secondary IDs

Study Sponsor

Lawson Health Research Institute

Study Sponsor

Stephen Pautler, MD, FRCSC, Study Director, Lawson Health Research Institute

Verification Date

January 2009